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Delhi High Court upholds foreign award in favour of daiichi (except qua minor respondents)
  • Khaitan & Co
  • Singapore, India
  • February 6 2018

By a judgment delivered on 31 January 2018, the Delhi High Court has held that the award passed in favour of Daiichi Sankyo Company Ltd. (the

Clinical trials lawyer welcomes FDA programme on Indian clinical trials
  • Leigh Day
  • India
  • July 14 2017

Clinical trials lawyer Gene Matthews has welcomed a push from the Federal Drug Agency (FDA) to promote safety and quality in clinical trials that are

Dietary Supplement & Cosmetics Legal Bulletin: January 2017
  • Shook Hardy & Bacon LLP
  • USA, India
  • January 19 2017

In December, the U.S. Food and Drug Administration (FDA) announced that it will make publicly available certain data received through the Center for

Ranbaxy loses FDA approval for two generics
  • Shook Hardy & Bacon LLP
  • USA, India
  • November 13 2014

According to a statement that Ranbaxy Laboratories Ltd. provided to the Bombay Stock Exchange Website, the U.S. Food and Drug Administration (FDA

FDA inspection finds CGMP violations at Bangalore facility
  • Shook Hardy & Bacon LLP
  • USA, India
  • 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

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

India-based company’s drugs barred from U.S. market
  • Shook Hardy & Bacon LLP
  • USA, India
  • January 30 2014

The U.S. Food and Drug Administration (FDA) has prohibited imported drug products from a Ranbaxy Laboratories, Inc. facility in India due to

Government slams Ranbaxy again over plant in India
  • Fish & Richardson PC
  • USA, India
  • January 28 2014

Last week the FDA announced that Ranbaxy's Toansa plant in India failed inspection the sixth Ranbaxy plant to cease making drugs for the U.S

Controller refuses compulsory license against Bristol Mayer’s Dasatinib
  • RNA Technology and IP Attorneys
  • India
  • December 11 2013

"Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses

India's new biosimilar guidelines and their relationship to the rest of the world
  • Dechert LLP
  • India
  • July 16 2012

The Indian Ministries of Health & Family Welfare and Science and Technology have released their Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India (the “Indian Guidelines”