Lecture titled, "Global Trends in API and Drug Product for GMPs" September 2013 Michael Anisfeld of Globepharm Consulting
Views: 3159 Regis Technologies, Inc.
Overview of the scientific and regulatory process and requirements for developing an API.
Views: 895 Cardinal Health
Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry. This webinar will cover: • Regulatory guidance (ICH, FDA, EMA) • Tests appropriate to different dosage forms • Dissolution specifications for immediate-release, modified-release and extended-release drug products • Dissolution specifications in the context of the biopharmaceutical classification system • Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination • Specifications for combination drug products • The role of specifications in maximizing drug product stability
Views: 1618 Pharmaceutical Training International
Ifotam -- Clever synthesis for demanding pharmacy. Ifotam CO.Ltd is one of the first spin off type companies in Poland, created on the basis of knowledge and experience of the research staff of the Center of Molecular and Macromolecular Studies (Polish Academy of Sciences, Lodz) and the Pharmaceutical Institute (Warsaw). The company was founded in 1989. Our activities are focused on search for, and development of, new methods of synthesis, transfer of technologies, production of APIs and sales of pharmaceutical substances. Many years of work on the company development have resulted in our current position of the one of more important manufacturers of first generation cytostatics in Europe. We specialize in synthesis of three groups of pharmaceuticals: - drugs used in anticancer therapies, - drugs used in treatment of skeletal system disorders, - protective drugs -- used in antitumor chemotherapy. On request of our clients, we also perform custom syntheses. Two production sites located in Łódź, with their laboratory and production facilities, allow to manufacture active pharmaceutical ingredients in quantities ranging from a few grams to 2 tonnes. Ifotam has at its disposal own, modern research and development laboratories, which enable us to launch new products efficiently, effectively and in a short time. Our highly qualified R&D Department staff makes it possible to develop new ideas as well as to search for, and to implement innovative solutions. That dynamically developing department of our company can take pride in numerous achievements and patents in the field of chemical synthesis, which have contributed to high quality and efficiency of our products. Ifotam has been also cooperating for many years with scientific institutions and research centers all over the world, which enables quick implementation of the latest advances in production of APIs. The products manufactured by Ifotam meet the requirements of current GMP. Owing to precise implementation of, and strict compliance with the GMP requirements, we gained the approval of FDA as early as 2001. We were one of the first companies in Poland positively assessed by international auditors. The active substances are manufactured in production centers specially designed for this purpose. Each substance is manufactured in the dedicated premises and the dedicated apparatus is used. High quality of our products, maintained consistently over a period of 20 years, is our asset. Our Quality Control Laboratory is responsible for monitoring the quality of products sold by us. The substrates using in the manufacturing processes, intermediates and final products are controlled there. All the procedures and instructions are based on the GMP guidelines. The Laboratory has analytical equipment allowing to perform all analyses in compliance with the Polish, European and US Pharmacopoeias. Ifotam is associated, first of all, with innovation, quality and timely delivery of products. We are a dynamically developing Polish enterprise supplying pharmaceutical companies all over the world. It is confirmed by the fact that export accounts for as much as 80% of our sales. We care about the satisfaction of our clients on such demanding markets as the USA, Germany, or Russia. Our partners have been cooperating with us with satisfaction for over 10 years. We supply products meeting the strict standards of the pharmaceutical market. Our products are: ifosfamide, cyclophosphamide, zoledronic acid, pamidronate disodium, risedronate sodium and others.
Views: 15244 Ifotam Co. Ltd.
The goal of API process validation is to ensure the reliable production of high-quality active pharmaceutical ingredients from development through commercialization. The product lifecycle approach established in FDA's 2011 Process Validation Guidance requires different validation activities during the process design and process qualification stages, as well as continued process verification throughout the life of the commercial process. The process validation needs for pre-qualification activities and ongoing process verification can be daunting, especially for small and medium-size pharmaceutical companies. In this webinar, experts on API process validation outline the key requirements for development of a phase appropriate manufacturing plan including regulatory requirements, data collection, specification development, critical process parameters, sampling plans, and analytical method validation. Key Learning Objectives: * Understand the regulatory expectations at each clinical phase. * Determine the key validation aspects of API manufacturing including critical process parameters. * Identify analytical and stability needs as the API advances in the clinic. Moderator: Rita Peters Editorial Director Pharmaceutical Technology Speakers: Paul Wrezel, Ph.D. Director of Analytical Method Development Regis Technologies Bikash Chatterjee President and Chief Technology Officer Pharmatech Associates Inc. Paul L. Pluta, PhD Editor-in-Chief Journal of GXP Compliance and Journal of Validation Technology
Views: 13431 Regis Technologies, Inc.
Process validation is mandatory in pharmaceutical manufacturing. Process validation is an important part of good manufacturing practices(GMP) in pharmaceuticals. Details: https://www.pharmaguideline.com/2017/10/basic-requirements-for-process-validation.html ------------------------------------------------ #Pharmaguideline provides all pharma information and #pharmaceutical guidelines including information about testing procedures of quality control, calibration, reagents and solutions, glassware and good laboratory practices (GLP), audit checklists of all departments for QA professionals. It also covers quality assurance topics such as change control, deviations, market complaints, process validation, cleaning validation cGMP and other pharma documentation and guideline. A fresher in the pharma field can get all latest information about GMP guidelines for QA, QC, Production and Microbiology. Pharmaceutical Guidelines App provides all recent pharma news updates from the world with the alert for free. New articles are added every day to enhance the knowledge of pharmaceutical professionals. All pharmaceutical stuff can be found in one place. About 2500 topics have been covered to date and counting. Pharmaguideline is the total pharmaceutical solution for professionals as well as students. Join us Youtube - https://go.pharmaguideline.com/youtube Facebook -https://go.pharmaguideline.com/facebook LinkedIn - https://go.pharmaguideline.com/linkedin Twitter - https://go.pharmaguideline.com/twitter Blog - https://www.pharmaguiseline.com
Views: 11149 Pharmaguideline
Pecha Kucha for Quality Assurance Assignment
Views: 3901 yousra mustafa
Micro-dosing in Today’s Pharmaceutical Industry Micro-dosing is the procedure of dispensing precise amounts of drug substance into capsules (powder-in-capsule or PIC). The PIC approach can help on two levels: 1. Speed- it enables a jump start on feasibility and first-in-human studies. Valuable data is obtained to help with the drug substance’s life cycle. 2. Assessment- drug substances’ physical characteristics are ever-changing and becoming more challenging. Flow properties, particle size, hygroscopicity, and particle morphology are obstacles to overcome during formulation development. Parallel studies can be conducted to help understand the nature of the drug substance without losing valuable time during feasibility studies. Capsugel’s proprietary Xcelodose® Precision Powder Micro-dosing System facilitates the PIC approach by providing accurate, consistent and automated fill across compound types inclusive of very low dose applications. Xcelodose Systems have become the industry standard for micro-dosing with rapid PIC manufacture and fill accuracy to 100 micrograms. Micro-dosing best practices have been developed by Xcelience, based on the experience of more than 600 batches and 200 compounds, utilizing Xcelodose Systems to reduce product development time by 13-17 weeks.
Views: 224 Capsugel
pharmaexcipients.com is the largest online platform on pharmaceutical excipients. The daily blog articles are shared with stakeholders from the industry and academia covering product development, purchasing, manufacturing, regulatory and many other engaged with pharmaceutical excipients and their use. The information shared on the site and in the daily blog cover different angles of the pharmaceutical excipients and shall increase the knowledge on the inactive but functional parts of a drug product. pharmaexcipients.com includes sourcing and sales of pharmaceutical excipients. Our experts can investigate alternative manufacturers for a specific demand. We create access to experts and outsourcing partners in different fields.
Views: 1769 pharmaexcipients
21 October 2015, Brussels Conference with representatives of the European Directorate for the Quality et Medicines & Healthcare (EDQM), of the European Federation of Pharmaceutical Industries and Associations (EFPIA), of the European Federation Association of Chemical Distributors (FECC), of the European QP Association and of the delegation of China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) together with major Chinese industrial API manufacturers.
Views: 1409 CODEMA PHARMA
Expert Regulatory Capabilities. Assured cGMP Excellence. At LGM Pharma, we pride ourselves on customizing products and services to fit our clients' requirements. Our clients come from a diverse array of scientific research & development disciplines from around the world, including: Pharmaceutical Manufacturers Formulation / DDS Companies Generic Pharmaceutical Companies Biotech & Specialty Pharma CROs, CMOs and CDMOs R&D & Specialty Pharma Academic & Government Laboratories Chemical Catalog Companies As an R&D driven company, LGM focuses on developing cutting-edge solutions that enable our client to realize significant qualitative and measurable cost and time benefits in the ‘drug discovery to market’ value chain. When it comes to purchasing your API’s, we believe that quality is key! We have the required capability to deliver products and services across the pharmaceutical value chain. To make our business model truly comprehensive, we have embarked upon API Custom Synthesis and cGMP Manufacturing Services. LGM has a global footprint with modern cGMP manufacturing and R&D plants located across the US, Europe, India and China. We work with leading pharmaceutical companies across the globe to address their challenges. LGM business development managers are always present at every international API tradeshow, in order to ensure that our clients get the full benefit of cutting edge information on the newest APIs, innovative technologies and current pharmaceutical market trends Due to our logistics experience and relationships with top class forwarding agents worldwide, we are able to offer specialized shipments that are suited for the pharmaceutical products. We pride ourselves on customizing our APIs and regulatory services to suit our clients requirements. Some of the therapeutic categories that we handle include the following : Analgesics Anthracyclines Anti-Asthmas Anti-Diabetics Anti-Fungals Anti-Hyperlipodemics Anti-Hypertensives Anti-inflammatories Anti-Migraines Anti-Neoplastics Anti-Obesity Products Anti-Retrovirals Anti-Ulcerants Antibacterials Antibiotics Anticonvulsants Antidementia Agents Antidepressants Antiemetics Antihyperphosphatemics Antiparkinson Agents Antipsoriatics Antipsychotics Antithrombotics Antivirals Blood Glucose Regulators Blood Products Cardiovascular Agents Gastrointestinal Agents Gliptins DPP-4 inhibitors Hormonal Agents Hypocalcemias Immunological Agents Immunosuppressants Monoclonal Antibodies Osteoporosis Products Prostaglandins Respiratory Tract Agents Synthetic Peptides
Views: 262 LGM Pharma
Lexaria Bioscience Corp (CSE: LXX) CEO Chris Bunka says the drug-delivery technology company is poised for growth in the year ahead. "We help other companies deliver their drugs, or what we call API's, active pharmaceutical ingredients," says Bunka. The company is based in Kelowna, British Columbia. Bunka says the company helps other companies with drug delivery methods create products that "taste better, smell better and act more quickly." This includes items such as cannaboids, vitamins, NSAIDs, PDE5 inhibitors, nicotine and other molecules. Lexaria has multiple patents pending in over 40 countries and has patents granted in the USA and in Australia for applications of its DehydraTECHTM delivery technology Bunka says recent growth at the company has been brisk, however, says more and more jurisdictions are making cannabis edibles legal, which is good news for the company.
Views: 1075 Proactive Investors Stocktube
How to know about API In Pharma Industry || Active Pharmaceutical Ingredients || PHARMA GUIDE || In this video, we are discussing Active Pharmaceutical Ingredients. In these Active Pharmaceutical Ingredients plant, different types of departments are involved. Those are 1. Production 2. Quality control 3. Quality assurance 4. Research & Development 5. Electrical & Mechanical Department 6. Stores In Active Pharmaceutical Ingredients, two or more Ingredients are reacted at a certain temperature and it's produced one product, it is commonly called as the Final product. The starting two or more Ingredients are purchased from Bulk industry. In these Active Pharmaceutical Ingredients, we are using different types of equipment, those are Reactors, centrifuges, filters, valves, dryers, condensers, and receivers. Then we go for Documents, The several Documents are BMR- Batch manufacturing records CR- Cleaning records EUR- Equipment usage records CR- Deviation records SOP's- Standard operating procedures Temperature monitoring sheets Logbook Process: The process is involved in following steps, those are, 1. Selection of Raw materials 2. Weighing of Raw materials 3. Charging 4. Mixing or agitation or stirring 5. High heating 6. Cooling 7. Sedimentation 8. Drying (water) 9. Purification 10. Drying(vacuum) 11. Unloading 12. Packing 13. Labelling After finishing of labelling it is called as Final Product. The Final product is sent to the Formulation plant through the vendor. #pharmaguideradhakrishna #PharmaGuide
Views: 20551 Pharma Guide
This Video provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations. This Video is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements. This webinar will address the basic Drug Development Process, nonclinical trials and human clinical trials. In addition the two major FDA submissions during Drug Development will be covered - the IND submission and the NDA submission. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/JGhy/
Views: 27928 GlobalCompliance Panel
The successful filing of an Investigational New Drug application (IND) is a pivotal milestone for an emerging pharma company. This webinar is designed to address this crucial topic for the key industry segment. Citing the FDA website for an Investigational New Drug Application, “Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.” This webinar is geared towards smaller pharma companies filing an IND for the first time but even experienced drug developers could benefit from an overview of the requirements and considerations. The goal of the webinar is to educate and enable our listeners in pursuit of this key objective. While this particular talk is geared towards small molecule active pharmaceutical ingredients (API) and drug products, much of it applies to biologic products as well. The Webinar features three prominent experts in the pharmaceutical development arena and each will highlight a different facet of the IND process. Jennifer Stanek has over 20 years of experience with key roles in CMC regulatory affairs, formulation development and analytical development. She has expertise in the coordination, preparation and management of global clinical trial applications, new marketing registrations, drug master file applications and their life-cycle management. Ms. Stanek began her career at G.D. Searle, moved into CMC consulting and is currently with Takeda where she serves as Director in Global Regulatory Affairs CMC. Jennifer will be providing an overview of the US IND format including an explanation of Modules 1-5, CMC (Chemistry, Manufacturing & Controls) submission timings, FDA meetings (timing, preparation, etc), and other CMC considerations. Dan Weissmueller is the Director of Quality at Regis Technologies. Dan’s experience and expertise include analytical development, process and analytical validation, IND support to Regis’ custom API customers, Drug Master File (DMF) regulatory approvals worldwide and FDA inspections. Dan has been with Regis for about 15 years where he has worked with numerous early phase API developments candidates and been the responsible person for the fillings of 3 approved drugs in over 20 countries. Dan is in the process of completing his Masters’ in Quality and Regulatory Sciences from Northwestern University. Working from the perspective of a custom manufacturing organization (CMO) quality assurance director, Dan has seen both the good and bad in terms of a customer’s preparation for an IND filing. Dan will be highlighting aspects of drug substance development and cGMP scale up as it applies to the IND requirements for small molecule API’s. Topics include the development lifecycle, validation considerations, equipment qualification and risk management. Steve Pondell brings over 30 years of experience in manufacturing and serves as Vice President of CMC at ESSA Pharmaceuticals and previously as a Principal at Integrated Biotech Solutions in Houston, Texas. Steve is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production. Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analysis, Phase I product development programs, and cGMP compliance. Steve will focus his talk on the IND requirements for Drug Product along with the corresponding analytical considerations. Topics include container/closure, dosage form (e.g. oral, injectable, etc), analytical method requirements, specifications, validation requirements and product stability.
Views: 4642 Regis Technologies, Inc.
The success of a new chemical entity (NCE) relies on the preformulation screening of lead candidates and robust and efficacious formulation development based on the compound’s physicochemical and biopharmaceutical properties. Early stage prediction of these properties is beneficial in selection of suitable technologies in optimizing the bioavailability, safety, and stability of the NCE candidate. Intuitive design of suitable formulation for clinical studies streamline pharmacokinetic and efficacy/toxicity studies leading to pharmacologically effective and developable candidates to reach the clinic and eventually the market faster. Working with reliable and well-established partners with the expertise in preformulation and formulation development results in substantial cost savings and expedites successful development of candidates from clinical to market.
Views: 4397 InformEx Events
Dr. Steven Baertschi delivered this talk in South San Francisco, CA on October 31, 2018. Development and implementation of impurity control strategies is a complicated, yet critical process necessary to ensure overall pharmaceutical product quality and patient safety. Existing guidelines for control of new impurities in drug substances and new drug products (ICH Q3A/Q3B, USP Chapters 476 & 1086) apply to commercial products or products in late-stage clinical development (Phase 3). In addition, guidance for mutagenic impurities (ICH M7), which covers early clinical development through commercialization, is a relatively new guideline and questions regarding its implementation remain. The lack of regulatory guidance regarding impurity controls at early stages of clinical development (prior to Phase 3) provides both questions and opportunities for the development of effective control strategies. This talk focuses on risk-based, chemistry-driven approaches to speeding the development of organic impurity control strategies throughout clinical development. Relevant examples and references are provided.
Views: 173 Regis Technologies, Inc.
Hello Friends , here is the next video in the learning pharmacy series.... In this video , we have discussed about Pharmacy Online Lecture | Pharmaceutics-Ch-1 | Dosage Forms Of The Drugs I In Hindi | हिंदी में We tried to prepare the best content for you so watch the video until the end. #GPAT #NIPER #DRUG #INSPECTOR #Pharmacy #competitive #Exams Recommended book for more practice - http://amzn.to/2vjTLP7 BE WITH US FOR MORE EXCITING VIDEOS. PROUD TO BE PHARMACIST ------------------------------------------ Share, Support, Subscribe!!!. Subscribe: https://www.youtube.com/channel/UCJHtUUFE8lnVsf1o2FJODJQ?sub_confirmation=1 Youtube: https://www.youtube.com/channel/UCJHtUUFE8lnVsf1o2FJODJQ/about Topic discussed in the video :- 1-Introduction 2-Classification & Example 3-Brief Explanation of all the dosage forms 1-Introduction of Dosage Forms Of Drugs Dosage forms are the career/medium through which drug molecule are delivered to the site of action within the body. Every dosage form is a combination of drug and non-drug components called Excipients. 2-API (Active Pharmaceutical Ingredient) & Excipients API are the chemical compound that are actually used for diagnosis, treatment & prevention of disease. Excipients are used to give particular shape to the formulation, to increase stability, palatability and to make the preparation more elegant. 3-Excipients Coloring agents, Suspending agents, Binding agents,Solvents & Lubricants, Perfumes, Sweetening agents, Flavoring agents Solubilizing agents, Antioxidants 4-Solid Dosage Form a-Tablets are unit dosage Form consisting of active Ingredient & suitable Pharmaceutical Excipient. Tablets may vary in size, shape, weight, hardness & thickness & in other aspects b-Capsules are unit dosage form consisting of gelatin shell that breaks open after the capsule has been swallowed, these are of two types e.g. Hard & Soft gelatin capsule 1-Hard Gelatin Capsule-two pieces fit together and hold the drug, either powder Or granular form. 2-Soft gelatin Capsule-one piece with drug usually in liquid form inside the shell c-Unit dosage form meant for one time use e.g. ENO powder d-Small rounded solid dosage form containing medicament intended for oral use, pills are rarely used nowadays. e-Powders are finally divided solid drugs or mixture of drugs for e-internal or external use. Dusting powder Granules Sachets f-Insufflation is the act of blowing something (such as a gas, powder, or vapor) into a body cavity g-Dentifrices, including toothpowder and toothpaste, are agents used along with a toothbrush to clean and polish natural teeth. 2-Liquid Dosage Form Elixirs are solution that contain alcohol and water base, sugar & flavoring agent commonly used for pediatrics and elderly patients who have difficulty in tablet swallowing. Syrups Do not contain alcohol and are concentrated solution of sugar, water & flavorings. They are sweeter and more viscous than elixirs. Linctus are Thick liquid medicine especially used for dry cough. Drops Are the solutions prepared by dissolving one or more solute in a solvent. E.g. eye drop, ear drop, nasal drop, oral drops Emulsions Are dispersion system containing two immiscible liquids and are of two types o/w & w/o e.g. cod liver oil emulsion Suspensions Are dispersion system in which solid particles are dispersed in liquid phase E.g. Most of the injections 3-Semi-liquid Dosage Form Suppositories Are small, round or cone-shaped object that you put in your body, often into your bottom. Once it's inside, it melts or dissolves and releases its medication. Passaries Are a small soluble block that is inserted into the vagina to treat infection or as a contraceptive. Ointments-An oil-based preparation that is applied to the skin or mucus membrane.Neosporin ointment For bacterial infections. Creams-A cream is a preparation of a medication for topical use (on the skin) that contains a water base. Hydrocortisone cream for skin irritation. Paste/jellies 4-Other Dosage Form Inhalers & Aerosols CONNECT WITH US ON OUR SOCIAL NETWORKING SITES:- FACEBOOK https://www.facebook.com/learningpharmacy.in/ TWITTER https://twitter.com/learn_pharma GOOGLE + https://plus.google.com/100078152149559945911 WEBSITE http://learningpharmacy.weebly.com/ FOR BUSINESS ENQUIRIES EMAIL US: [email protected] SHARE YOUR SUPPORT ON PATREON PAGE https://www.patreon.com/learningpharmacy ------------------------------------------ Do Let Us Know if you want us to create videos on specific topic. ------------------------------- Background music of the video - Dream Culture by Kevin MacLeod is licensed under a Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/) Source: http://incompetech.com/music/royalty-free/index.html?isrc=USUAN1300046 Artist: http://incompetech.com/
Views: 262504 LEARNINGPHARMACY.IN
Cytopharma is the first pharmaceutical company in Africa & Middle East region that is fully dedicated to the manufacturing and marketing of generic cytotoxic drugs. We care about your patients Established in Tunisia since 2011, Cytopharma's purpose is to provide high quality and affordable oncology medicine for cancer patients all over the world, helping them successfully fighting the disease. Cytopharma has a production line of injectable oncology products in both liquid and lyophilized forms. Our steadily growing product portfolio is currently counting five molecules : Fluorouracil (5-FU) - 250, 500 and 1000 mg Oxaliplatin - 50 and 100 mg Epirubicin - 10 and 50 mg Paclitaxel - 30, 100 and 150 mg Docetaxel - 20 and 80 mg As we are expanding our business towards Africa, Middle East and Europe, we are open to any kind of partnership : distribution, contract manufacturing, co-promotion, co-marketing ...
Views: 911 Cytopharma Oncology
The ban on the import of APIs from China may lead to possible shortages of antibiotics, and anti- diabetes, anti-psychotic and antacid drugs, say pharma lobby groups Subscribe Now For Latest Updates- https://tinyurl.com/lbw8nze
Views: 707 Mint
Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products. Are you looking for pharmaceutical ingredients and the companies that are manifacturing them and where you can order them? Here at xxx you can find the API you are looking for. We will be very happy to assist you as well if you have questions. You find the following products on our Website: API: Abiraterone Acetate Apixaban Articaine Bendamustine Brinzolamide Cyclobenzaprine Dorzolamide Doxercalciferol Granisetron Ivabradine Mefloquine Nepafenac Trandolapril Olopatadine Palonosetron Paricalcitol Warfarin Sodium Pralatrexate Sitagliptin Phosphate Remifentanil Propofol Linagliptin Temozolomide Irbesartan Hydroxychloroquine Sulfate Dabigatran etexilate mesylate. Read now. Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products AZAD API R&D AZAD focuses on molecules that are complex to synthesize both from a process as well as patents points of view. The process development is managed under the supervision of AZAD’s own chemists based in Schaffhausen Switzerland. The route of synthesis is developed at a contract developer notably one that can also do the upscaling and the commercial production. Most of the contract developers are in Europe. AZAD Drug Products R&D AZAD is building a portfolio of Drug Products, in order to complement its substantial range of Active Pharmaceutical Ingredients. Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products Company Profile AZAD, a privately held company, was established in 2000 to exclusively handle Cilag’s global sales and marketing activities of Active Pharmaceutical Ingredients (APIs). Soon after, AZAD began to diversify its field of expertise in order to broaden its offerings and extend its presence in the healthcare industry. Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products 2016 – July – CPhI Barcelona Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products 2015 – February – CPhI Madrid AZAD Pharma AG and AZAD Pharmaceutical Ingredients AG will Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products Was sagt Wikipedia zu Brinzolamide Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products Christina Meier Kirchweg 6 6423 Schwyz Schweiz Facebook Map Mehr zum Thema Buy pharmaceutical products like bendamustine brinzolamide iron sucrose timolol – active pharmaceutical ingredients manufacturers API like amorolfine ketorolac – order pharma products
Views: 94 Meier's Youtube
Between May 1 and June 1 of each year, operators of facilities that produce generic drugs and generic drug active pharmaceutical ingredients (APIs) must submit self-identification information to FDA. FDA uses this information to determine which user fees a facility is subject to under the Generic Drug User Fee Amendments (GDUFA). Fiscal Year (FY) 2018 introduced numerous changes to GDUFA, including new contract manufacturing organization facility fees, abbreviated new drug application (ANDA) program fees, and more. Registrar Corp's webinar covers the self-identification process and recent developments under GDUFA, concluding with a live Question & Answer session.
Views: 260 Registrar Corp
Click here for more Information:http://www.audioeducator.com/pharma-biotech/pharmaceutical-api-drug-substance-excipients-raw-materials-testing-01-20-2015.html Pharmaceutical API, Drug Substances, Excipients and Raw Materials Testing Presented By:Dr. Jerry Lanese Know the Best Practices for Documentation of Medical Necessity, Critical Care and Other Timed Services! More Videos: - http://www.youtube.com/user/audioeducator2 You can also connect with us on Twitter, Facebook, Google+ and LinkedIn and get the most updated news and views, expert advice and tips to help resolve your coding, billing & compliance dilemmas quickly and accurately. Connect with us on Twitter: - https://twitter.com/audioeducator Facebook: - https://www.facebook.com/pages/AudioEducator/244912592201260 LinkedIn: - http://www.linkedin.com/company/audio-educator Google+: - https://plus.google.com/102668946943256059069/posts
Views: 323 AudioEducator
Moving from drug discovery to drug development requires a particular skillset usually not yet honed by start-ups. This phase of the development process is highly regulated and critical. Let Dr. Colin Minchom take you through the aspects of the Chemistry, Manufacturing and Control (CMC) portion of the drug development process. Watch this video to learn about the pharmaceutical product development which includes objectives of formulation, cost-effective strategies to reach key milestones and more. MaRS -- Building Canada's next generation of global technology companies. marsdd.com
Views: 29010 MaRS Entrepreneurship Programs
The video-clip 'Phases of pharmaceutical industry' presents, step by step, the medicine line production. A 2D animation presents both the individual phases and the overall picture of the process. The students familiarize with the requirements and the conditions of medicine production, the required technology and the importance of health and safety specifications. What follows is the acquaintance with the methods of product qualitative control, the role of the head pf production and issues of waste management. The clip is instructional as far as medicine production is concerned and can be used as an introduction to the topic 'Industries' and 'Pharmacy'.
Views: 212603 EducationalTVGreece
Real Time Release Testing of Pharmaceutical Drug Products: How Does Raman Measure Up? NIR spectroscopy is widely developed and implemented as a PAT measurement tool. NIR based assay of pharmaceutical solid dosages has been implemented for real time release testing of tablets. Considerable effort is required in not only developing robust multivariate models for NIR, but also maintaining them during the product life cycle. A systematic risk assessment has shown that a large number of factors could impact the NIR measurement. In contrast, Raman spectroscopy methods can be developed and deployed relatively easier compared to NIR. During the webinar, modeling efforts and performance for assay of the same product will be compared for NIR and Raman measurements. Additional examples will also be presented to demonstrate Raman as a robust and real time assay tool for both pharmaceutical solid dosages and biological products.
Views: 239 Kaiser Optical Systems
We produce tablets, capsule, granules, injection and API, total 49 drug approval numbers and other intermediates. There are 4 API workshops, and two solid preparation plants, injection plants with GMP. Annual production capacity of 100 tons of raw material, solid dosage form annual output of 3 billion, injection annual output 1.3 billion bags. The drug products are widely used in the most provinces of china, and API exports to all over the world.
Views: 3 Xi‘an Wanlong Pharmaceutical
Development of a drug product By Dr. Orna Dreazen- Nextar
Views: 367 Nextar Chempharma Solutions
In this tutorial, I will discuss about Top 5 frequently asked interview questions on Stability studies from ICH and FDA guidances. Here is the link of previous tutorials, For exhibit batch size requirements for ANDA Part-2: https://youtu.be/93axDflz_oI Part-2A: https://youtu.be/IPt4gUb78Y8 To learn about significant changes. https://youtu.be/EsFrZcA58CE Q.1 Is “significant change” appplicable only for accelerated storage condition? Or is it applicable for Long-term study too!? Q.2 How many A P I lots are required to manufacture three batches, of each strength, of a proposed drug product? Q.3 what are various storage conditions for stability and its time points? Q.4 If one out of the three batches is stored under accelerated conditions, shows a significant change, what should be done? Q.5 How long do the three pilot scale batches, need to be stored before destruction which were submitted as a part of an ANDA?
Views: 7073 Pharma Learners
What is ME-TOO COMPOUND? What does ME-TOO COMPOUND mean? ME-TOO COMPOUND meaning - ME-TOO COMPOUND definition - ME-TOO COMPOUND explanation. A me-too compound or follow-on drug is a drug product that contains an active pharmaceutical ingredient (API) that is chemically related, and usually very structurally similar, to an existing active pharmaceutical ingredient. The me-too may differ in some respects from the prototype API (i.e., different side effect profile, or more or less active), but uses the same mechanism and is used for the same purpose as the original. The term is usually used in a negative way, the idea being the me-too drug simply rode the coattails of the research and development done to develop the prototype API, but the compounds can serve as market competition, driving prices down. A me-too compound is a drug product that contains an active pharmaceutical ingredient (API)—in common parlance, "a drug"—that is chemically related, and usually very structurally similar, to an existing active pharmaceutical ingredient. The me-too may differ in some respects from the prototype API (i.e., different side effect profile, or more or less active), but uses the same mechanism and is used for the same purpose as the original. The term follows from the phrase "me too" and is usually used in a negative way, the idea being the me-too drug simply rode the coattails of the research and development done to develop the prototype API. Me-too drugs can be novel compounds themselves, and drug products containing them can serve as market competition, driving prices down; similarly active compounds are exhibited soon after a novel API is made available.
Views: 9 AZ Production
Rate My App is your new daily show for developers and enthusiasts who want to learn about product design and user interface design. Improve every morning by watching video walkthroughs of brand new Show HN and Product Hunt products in your daily commute or shower. Here's a looksie of the AWS API Gateway! Thanks for watching this video. Sign up now for the Rate My App newsletter (http://ratemyapp.com/newsletter) to get access to news of a morning podcast before anyone else. It's free and your email will never be spammed.
Views: 478 Rate My App
What is Significant Change in Pharmaceutical Stability Testing? Or Can you explain what do you mean by significant changes? This is the one of the frequently asked question in the interview. In this tutorial you will learn how to define “Significant change” in a drug product or drug substances, according to ICH Q-1E guideline.
Views: 7329 Pharma Learners
Stability studies are routinely carried out in the industries in order to measure the degradation of a product. Steven Wachs provides useful tips for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life. Buy the full version of the webinar at http://bit.ly/Stability-Studies More webinars on Stability Studies: 1. http://bit.ly/Design-Execution 2. http://bit.ly/Stability-Testing 3. http://bit.ly/Product-Stability
Views: 10279 OnlineCompliancePanel
Salesforce's Einstein image prediction works well for detecting common everyday objects like a cat, or an iphone or scenary like a beach or a mountain. When applied to drug product packaging, the detection was decent, but I only trained it on 3 brands. If the image was the back of the box, it doesn't predict that well. I'm guessing it is because the text is either slanted or upside down. My lesson learned is that trying to detect what product it is based on packaging is probably a poor use case for this API. Most boxes look the same, and many brands have the same color. A better choice would be to use a text recognition API to extract the text. Or go back to barcode scanning which should be really accurate.
Views: 615 Peter Yeung
Contact us for more information on your pharmaceutical manufacturing processes and how we can make then safe for your operators and your products. We're happy to advise on any aseptic or containment issues you might have. Contact us at [email protected] or ring through to relevant numbers that you can find here: http://extract-technology.com/contact/contact-us/
Views: 10675 Extract Technology
Warren Perry, GRCP, Compliance Consultant, QUMAS discusses the issues that are facing Generic Pharma companies and API manufacturers that operate outside North America and Europe. Perry also discusses how the FDA GDUFA mandate requires Quality Management systems that include document management and process managment (CAPAs, deviations, complaints, change controls etc.) to be in English in order for submissions to be inspected. To conclude Warren briefly addresses the emerging role of the PIC (Pharmaceutical Inspection Corporation) inspections standard.
Views: 1435 QUMAS Inc
Click here to register for free and to view the entire webinar: http://xtalks.com/Practices-Global-Drug-Product-Labeling-Management.ashx?utm_source=YouTube&utm_medium=Teaser&utm_campaign=XT0776_Sciformix Speakers: Bindu Narang, Director of Scientific Writing and Regulatory Affairs, Sciformix Boris Jankowski, Director of Solutions Architecture, Sciformix Craig Trautman, CEO, Intagras Drug product labeling is continuing to grow both in complexity and strategic importance as the key document for communication of benefit: risk to health care professionals and patients. Life science companies not only have to ensure harmony of messaging from Core Data Sheet to Local Prescribing Information, but also track and document the implementation of labeling changes and any local variations. In addition, there is increasing pressure by Health Authorities to demonstrate overall performance, quality and compliance of the end-to-end labeling process. To address these challenges, a unified global labeling continuum that coordinates upstream (i.e. signal detection) and downstream (i.e. the printing and distribution of the label) activities requires an integrated services, process and technology model. This webinar will focus on translating current business drivers and challenges within the global drug product labeling domain into a set of opportunities and next-generation operating models that support scale, efficiency, quality and compliance. Viewers will learn: What is driving labeling complexity in terms of internal pressures, such as global expansion and evolving global health authority expectations What the future looks like with regards to the seamless integration of the end-to-end labeling process (from signal to package) coupled with external services and technology enablers How to assess the overall performance and quality of the labeling process
Views: 269 Xtalks Webinars