Orange Book

What is Orange Book?

• It is the commonly used name for the book “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is published by USFDA.

• It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.

• FDA was required to publish orange book under Drug, Price and Competition Act (1984) which is also known as Hatch-Waxman Act

Orange book doesn’t cover-

• Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal Tablets and  Librax Capsules]

• Pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. 

Other important facts-

• The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.

• Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product.

• The List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs.

• Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act.

We can search all the orange book listed approved drug products in the FDA’s website by using any of the following search options

• Search by Active Ingredient
• Search by Applicant Holder
• Search by Proprietary Name
• Search by Application Number
• Search by Patent

Search all the FDA approved Drug Products

Download link for 31st edition of e-orange book

Keywords: Approved Drug Products with Therapeutic Equivalence Evaluations, Drug, Price and Competition Act or Hatch-Waxman Act, Drug Efficacy Study Implementation [DESI], Pre-1938 drugs, multisource prescription drug, orange book listed approved drug products, Active Ingredient, Applicant Holder, Proprietary Name, Application Number,  Patent

References-

http://www.wikipedia.org/

http://www.fda.gov/

All About Pharmaceutical Giants: Cipla

                                                        

Cipla Limited is a prominent Indian pharmaceutical company, best-known outside its home country for manufacturing low-cost anti-AIDS drugs for HIV-positive patients in developing countries was founded in 1935 by Dr Khwaja Abdul Hamied. In 1935, he set up The Chemical, Industrial & Pharmaceutical Laboratories, which came to be popularly known as Cipla. He gave the company all his patent and proprietary formulas for several drugs and medicines, without charging any royalty. On August 17, 1935, Cipla was registered as a public limited company with an authorised capital of Rs 6 lakhs.

All About Indian Pharmaceutical Giants: Dr Reddy's Labs

Introduction

Dr. Reddy's Laboratories Ltd. founded in 1984 by Dr. K. Anji Reddy, has become India's second biggest pharmaceutical company. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients for drug manufacture, diagnostic kits, critical care, and biotechnology products.

Dr. Reddy's began as a supplier to Indian drug manufacturers, but it soon started exporting to other less-regulated markets that had the advantage of not having to spend time and money on a manufacturing plant that that would gain approval from a drug licensing body such as the U.S. Food and Drug Administration (FDA). By the early 1990s, the expanded scale and profitability from these unregulated markets enabled the company to begin focusing on getting approval from drug regulators for their formulations and bulk drug manufacturing plants in more-developed economies. This allowed their movement into regulated markets such as the US and Europe.

By 2007, Dr. Reddy's had six FDA-plants producing active pharmaceutical ingredients in India and seven FDA-inspected and ISO 9001 (quality) and ISO 14001 (environmental management) certified plants making patient-ready medications – five of them in India and two in the UK.

In 2010, the family-controlled Dr Reddy’s denied that it was in talks to sell its generics business in India to US pharmaceutical giant Pfizer, which had been suing the company for alleged patent infringement after Dr Reddy’s announced that it intended to produce a generic version of Atorvastatin, marketed by Pfizer as Lipitor, an anti-cholesterol medication.  Reddy’s was already linked to UK pharmaceuticals multinational Glaxo Smithkline.

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Hi friends,

I started this blog to keep updated the students and other people associated with the profession of pharmacy. I will try my best to provide the latest information to all the pharma professionals.

But, I need to know how can I improve this blog. So, please send your valuable suggestions as comments to this post and I will do my best to provide the content.

Deepankar Gupta

All About Indian Pharmaceutical Giants: Ranbaxy

Company Profile

Ranbaxy Laboratories Limited (Ranbaxy), India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company, producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy today has a presence in 23 of the top 25 pharmaceutical markets of the world. The Company has a global footprint in 46 countries, world-class manufacturing facilities in 7 countries and serves customers in over 125 countries.