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Results: 1-10 of 143

FDA inspection finds CGMP violations at Bangalore facility

  • Shook Hardy & Bacon LLP
  • -
  • India, USA
  • -
  • June 26 2014

The U.S. Food and Drug Administration (FDA) has issued a warning letter to the president and CEO of Apotex, Inc., claiming that the agency's

Pharmaceutical healthcare update - medical devices in India

  • Clyde & Co LLP
  • -
  • India
  • -
  • June 15 2014

Medical Devices per se do not have a separate and distinct definition under India Laws. Medical devices covered under the definition of “drug” as has

Draft compensation formula for clinical trial related injury proposed

  • Nishith Desai Associates
  • -
  • India
  • -
  • June 12 2014

The office of the Drugs Controller General of India ("DCGI"), India's apex drug regulator, has published a draft formula for calculating compensation

EU agency will reinstate Ranbaxy’s GMP certificate

  • Shook Hardy & Bacon LLP
  • -
  • European Union, India
  • -
  • June 12 2014

The European Medicines Agency (EMA) has reportedly concluded its investigation of alleged non-compliance with good manufacturing practice (GMP) at

An overview of biosimilars and the biosimilar pathway in India

  • Michael Best & Friedrich LLP
  • -
  • India
  • -
  • May 21 2014

India is one of the most densely populated countries in the world. According to the World Bank (2012), 1.237 billion people live in India, accounting

The COPAXONE story in the U.S. and India: to stay or not to stay is the question

  • Michael Best & Friedrich LLP
  • -
  • India, USA
  • -
  • April 23 2014

As an update to our March 5th, April 4th and April 9th postings, The Copaxone Story in the U.S. and India, The Copaxone Story in the U.S. and India:

Sidley Austin LLP global pricing newsletter - volume three 2014

  • Sidley Austin LLP
  • -
  • Brazil, Canada, China, European Union, France, Germany, India, United Kingdom, USA
  • -
  • April 15 2014

On October 21, 2013, Brazil’s National Agency of Supplemental Health enacted Normative Resolution 388, which mandated that all private healthcare

The COPAXONE story in the U.S. and India: a further update

  • Michael Best & Friedrich LLP
  • -
  • India, USA
  • -
  • April 9 2014

As an update to our March 5th and April 4th postings, The Copaxone Story in the U.S. and India and The Copaxone Story in the U.S. and India: An

The COPAXONE story in the U.S. and India: an update

  • Michael Best & Friedrich LLP
  • -
  • India, USA
  • -
  • April 4 2014

As an update to our March 5th posting, The Copaxone Story in the U.S. and India, the U.S. Supreme Court (Supreme Court) this week granted Teva

Draft guidelines for examining pharma patent applications

  • Lakshmikumaran & Sridharan
  • -
  • India
  • -
  • March 19 2014

On February 28 2014 the Indian Patent Office issued draft guidelines for the examination of patent applications in the pharmaceuticals field