What is Fixed-dose combination (FDC) Drugs : Fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses & are in the spotlight currently due to government's ban on them. According to US healthcare provider IMS Health, almost half the drugs sold in India … Continue reading Fixed-dose combination (FDC) Drugs & its Ban in India
Month: December 2018
Good Distribution Practices (GDP) in Pharmaceutical Products
Good distribution practice (GDP) is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. Good Distribution Practice (GDP) refers to the regulatory guidelines governing the wholesale distribution of medicinal products to ensure their quality and integrity is maintained throughout the supply chain from the manufacturer to the end user. … Continue reading Good Distribution Practices (GDP) in Pharmaceutical Products
What is FMD (Falsified Medicines Directive) in pharmaceuticals Packing
The FMD (Falsified Medicines Directive) is a legal framework introduced by the European Commission to improve the protection of Public health within the European Union. The directive applies since 2 January 2013 & the European Commission Delegated Regulation, (EU) 2016/161, supplements Directive 2001/83/EC with rules regarding safety features for the packaging of medicinal products for human use. The regulation was adopted … Continue reading What is FMD (Falsified Medicines Directive) in pharmaceuticals Packing
Generics Drugs VS Branded Drugs and its Use in India you must Know
Generics Vs Branded Drugs What are Generic Drugs: Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts and it works … Continue reading Generics Drugs VS Branded Drugs and its Use in India you must Know
Indian Pharma Company Vision and Challenges
Introduction: The Indian pharma industry has been growing at a compounded annual growth rate (CAGR) of more than 15% over the last five years and has significant growth opportunities. However, for the industry to sustain this robust growth rate till 2020, companies will have to rethink their business strategy. India’s pharmaceutical industry has grown by Rapidly or … Continue reading Indian Pharma Company Vision and Challenges
ICH Guideline Q1 to Q14
For more Topic or contents you can click or refer to my another website named as pharmapathfinder.com What is ICH Guidelines : The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from … Continue reading ICH Guideline Q1 to Q14
Pharma Abbreviations
PVP : Process Validation Protocol PVR : Process Validation Report CVP : Cleaning Validation Protocol CVR : Cleaning Validation Report MQRM : Monthly Quality Review Meeting QRM : Quality Risk Management UCL : Upper control Limit LCL : Lower control Limit IPQA : In process Quality Assurance LLC : Live line clearance API: Active pharmaceutical ingredient … Continue reading Pharma Abbreviations
The Journey Begins
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