Active Pharmaceutical Ingredient Manufacturing
DOWNLOAD
Download Active Pharmaceutical Ingredient Manufacturing PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Active Pharmaceutical Ingredient Manufacturing book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Active Pharmaceutical Ingredients
DOWNLOAD
Author : Stanley Nusim
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Active Pharmaceutical Ingredients written by Stanley Nusim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
Active Pharmaceutical Ingredient Manufacturing
DOWNLOAD
Author : Girish K. Malhotra
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2022-04-19
Active Pharmaceutical Ingredient Manufacturing written by Girish K. Malhotra and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-19 with Technology & Engineering categories.
The book reviews current brand and generic business in pharmaceuticals manufacturing practices. Based on examples, the reader can interpolate, extrapolate and exploit mutual behavior of chemicals to design and commercialize processes that fulfill the demands, also considering the minimization of the environmental impact on effluents. Readers will be able to simplify process development, design and commercialize economic manufacturing processes.
Active Pharmaceutical Ingredients
DOWNLOAD
Author : Stanley Nusim
language : en
Publisher:
Release Date : 2010
Active Pharmaceutical Ingredients written by Stanley Nusim and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Drug development categories.
Handbook On Active Pharmaceutical Ingredients Api Drugs Pharmaceutical Products
DOWNLOAD
Author : Ashish Dey
language : en
Publisher: NIIR PROJECT CONSULTANCY SERVICES
Release Date : 2023-01-05
Handbook On Active Pharmaceutical Ingredients Api Drugs Pharmaceutical Products written by Ashish Dey and has been published by NIIR PROJECT CONSULTANCY SERVICES this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-05 with Antiques & Collectibles categories.
An active pharmaceutical ingredient (API) is the active substance in a pharmaceutical drug that produces its therapeutic effect. APIs can be synthetic chemicals or natural sources such as plant extracts. APIs are components of drugs, the majority of which are manufactured by pharmaceutical companies. Drugs, on the other hand, are dosage forms that contain an API and are distributed to patients for use. Pharmaceutical products are any compounds used in the medical industry to diagnose, treat, cure, or prevent diseases. These products are typically formulated as drugs, vaccines, biologics, and medical devices, which can either be prescribed by a doctor or bought over-the-counter (OTC). They come in various forms such as tablets, capsules, syrups, ointments, creams, solutions, suspensions, implants, patches, and powders. Pharmaceutical products are manufactured under strict guidelines and must adhere to various regulations such as Good Manufacturing Practices (GMP). The global market for Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products is expected to grow rapidly over the next few years. This growth will be driven by rising demand for improved healthcare services and an increasing number of new treatments. The market for active pharmaceutical ingredients is anticipated to rise at a CAGR of 5.90%. The development in the production of active pharmaceutical ingredients (APIs) as well as the increased incidence of chronic diseases including cancer and cardiovascular conditions are both responsible for the expansion. Government regulations that are supportive of API manufacturing, together with shifting geopolitical conditions, are accelerating market expansion. The pharmaceutical products market has grown steadily in recent years, and is expected to continue to do so. This growth is driven by a number of factors, including increased demand for new drugs, changing disease patterns and aging populations in some countries, as well as the emergence of innovative drugs and technologies. The market is being shaped by the rise of emerging economies and their increasing healthcare needs. This has led to increased investment in drug research and development, as well as an increase in the number of multinational companies setting up operations in various countries. Furthermore, generic drugs are becoming increasingly popular as a way of reducing healthcare costs. Generic drugs are copies of brand-name drugs, which are manufactured by generic drug companies. They offer an effective alternative to branded drugs and are often much cheaper. As a result, generic drugs are increasingly being used in countries across the world, leading to an increase in the global pharmaceutical products market. Overall, the global market for pharmaceutical products and drugs are set to continue to grow in the coming years. New products, innovative technologies and emerging markets will drive growth, and this will bring both opportunities and challenges for the industry. The books' main subjects include Active Pharmaceutical Ingredients (API), Drugs, Aspirin, Paracetamol, IV Fluids, Ointment, Metronidazole, Liquid Glucose, Surgical Cotton, Syrup, Tablet, Excipients, Pharmaceutical Salts with formulations, factory layout, and images of machinery with contact information for suppliers. A thorough guide to manufacturing and business operations in the Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products industry. The Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products manufacturing industry is full with opportunity for producers, traders, and business owners, and this book is your one-stop resource for all the information you require. The only complete manual on the creation of commercial Active Pharmaceutical Ingredients (API), medications, and pharmaceutical products is this one. It offers a wealth of information on how to do things, from concept through equipment acquisition.
Active Pharmaceutical Ingredients In Synthesis
DOWNLOAD
Author : Anthony J. Burke
language : en
Publisher: John Wiley & Sons
Release Date : 2018-11-28
Active Pharmaceutical Ingredients In Synthesis written by Anthony J. Burke and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-28 with Science categories.
Presents the most effective catalytic reactions in use today, with a special focus on process intensification, sustainability, waste reduction, and innovative methods This book demonstrates the importance of efficient catalytic transformations for producing pharmaceutically active molecules. It presents the key catalytic reactions and the most efficient catalytic processes, including their significant advantages over compared previous methods. It also places a strong emphasis on asymmetric catalytic reactions, process intensification (PI), sustainability and waste mitigation, continuous manufacturing processes as enshrined by continuous flow catalysis, and supported catalysis. Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development offers chapters covering: Catalysis and Prerequisites for the Modern Pharmaceutial Industry Landscape; Catalytic Process Design - The Industrial Perspective; Hydrogenation, Hydroformylation and Other Reductions; Oxidation; ; Catalytic Addition Reactions; Catalytic Cross-Coupling Reactions; Catalytic Metathesis Reactions; Catalytic Cycloaddition Reactions: Coming Full-Circle; Catalytic Cyclopropanation Reactions; Catalytic C-H insertion Reactions; Phase Transfer Catalysis; and Biocatalysis. -Provides the reader with an updated clear view of the current state of the challenging field of catalysis for API production -Focuses on the application of catalytic methods for the synthesis of known APIs -Presents every key reaction, including Diels-Alder, CH Insertions, Metal-catalytic coupling-reactions, and many more -Includes recent patent literature for completeness Covering a topic of great interest for synthetic chemists and R&D researchers in the pharmaceutical industry, Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development is a must-read for every synthetic chemist working with APIs.
Quality Rules In Active Pharmaceutical Ingredients Manufacture
DOWNLOAD
Author : John Sharp
language : en
Publisher: Interpharm CRC
Release Date : 2002
Quality Rules In Active Pharmaceutical Ingredients Manufacture written by John Sharp and has been published by Interpharm CRC this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002 with Medical categories.
The fifth booklet in the best-selling Quality Rules series presents the basic concepts of quality and current Good Manufacturing Practice (cGMP) in a manner easily understood by operators involved in the manufacture and quality assurance of active pharmaceutical ingredients (APIs). Drawing on the guidelines prepared under the ICH and made available by the US FDA, this booklet covers all the cGMP concepts required as training, retraining, and reinforcement resource for workers recently hired into the API manufacturing industry. In his familiar, no-nonsense style, the author explains the rationale of cGMP and the key role played by workers in the production and packaging of pure, safe, and quality APIs.
Active Pharmaceutical Ingredients
DOWNLOAD
Author : Stanley Nusim
language : en
Publisher: CRC Press
Release Date : 2005-05-25
Active Pharmaceutical Ingredients written by Stanley Nusim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-05-25 with Medical categories.
Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.
Exploratory Study On Active Pharmaceutical Ingredient Manufacturing For Essential Medicines
DOWNLOAD
Author : Janet Bumpas
language : en
Publisher:
Release Date : 2013
Exploratory Study On Active Pharmaceutical Ingredient Manufacturing For Essential Medicines written by Janet Bumpas and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with categories.
Active Pharmaceutical Ingredients (API) of good quality is core to the manufacturing of effective and safe essential drugs. The price of APIs is the main cost driver for manufacturing. Only a limited number of large manufacturers of finished pharmaceutical products have their own API manufacturing capabilities, and none of them can make all required APIs in-house. The majority of manufacturers, including all those located in Sub-Saharan Africa (with the exception of one company in South Africa) have to buy all APIs in the open market. The paper tries to make the structures of the API market more transparent, trying to determine how difficult it is for small manufacturers in developing countries to navigate the global API market and ensure that they get a quality product at a fair price. It also looks into the competitiveness of the market, trying to assess the risk that manufacturers or traders monopolize parts of the API market for essential medicines with low commercial attractiveness. The author confirms the initial assumption that the API market provides a challenge in particular to small manufacturers, who have limited means to verify the quality of the APIs they are buying. One potential way to address this problem would be to broaden the World Health Organization (WHO) prequalification system to include APIs for drugs that are on the WHO model list for essential medicines.
Pharmaceutical Vendors Approval Manual
DOWNLOAD
Author : Erfan Syed Asif
language : en
Publisher: CRC Press
Release Date : 2021-12-12
Pharmaceutical Vendors Approval Manual written by Erfan Syed Asif and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-12 with Business & Economics categories.
This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications. This book provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract Provided material can be easily tailored to incorporate changes to add in-house vendor’s qualification requirements. Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.
Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients
DOWNLOAD
Author :
language : en
Publisher:
Release Date : 2001
Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with categories.