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.

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.

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.

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

Annual Product quality review verifies the consistency of the existing manufacturing processes and determines the quality and process defects of the products. It also determines possible improvements of the methods and process and the trend of yield, analytical results, and manufacturing parameters of the product are also highlighted.Annual product quality review (APQR) shall be completed within 90 days; for example, Annual product quality review (APQR) for products manufactured during the period of January 2020 to December 2020 shall be completed by March 2021.

This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Indian doctors, schooled in Western science, are ignorant of the medical ethics of their own culture. They make a conscious effort to distance themselves from Ayurvedic medicine, in which the ethical codes are enshrined.Teachers and students forget that values have universal applicability, regardless of the mode of practice - Western or traditional - and that the patient remains the same regardless of the system.Unethical practices in getting entry into medical colleges as students.

India is the largest provider of generic drugs globally. The Indian pharmaceutical sector supplies over 50% of the global demand for various vaccines and, as a result, holds an important position in the global pharmaceutical sector. This book is a comprehensive study of pharmaceutical marketing management in the Indian context and similar growth markets. The book introduces the fast-paced and multi-faceted discipline of pharmaceutical marketing management through an in-depth discussion on the genesis and evolution of its marketing concept. Combining theory and practice, it offers a strategic approach to pharmaceutical marketing from an organizational and business perspective and explicates the practical applications of it. Richly supported by case studies, the book brings together fresh perspectives and approaches equally useful for students and professionals. This book will be of interest to academicians, advanced students, and practitioners of pharmaceutical marketing and pharmaceutical management. It will also be beneficial to those interested in business strategy, decision-making, and international marketing.

This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory, and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry” for the 5 years pharmacy curriculum, but the textbook is also intended for analytical chemists moving into the field of pharmaceutical analysis. Addresses the basic concepts, then establishes the foundations for the common analytical methods that are currently used in the quantitative and qualitative chemical analysis of pharmaceutical drugs Provides an understanding of common analytical techniques used in all areas of pharmaceutical development Suitable for a foundation course in chemical and pharmaceutical sciences Aimed at undergraduate students of degrees in Pharmaceutical Science/Chemistry Analytical Science/Chemistry, Forensic analysis Includes many illustrative examples