India's Lupin says it sees no supply disruption at plant despite FDA observations

[March 29, 2016]  MUMBAI (Reuters) - Lupin Ltd, India's third-largest drugmaker, said on Tuesday it did not expect any disruption to supply from its main manufacturing plant despite what it called minor observations made by the U.S. Food and Drug Administration after an audit.

Shares of the company fell as much as 14 percent to their lowest in about one-and-a-half years after CNBC TV18 reported about the observations at two units of the Mandideep facility in the central Indian state of Madhya Pradesh.

The company did not clarify what the observations were but said in a statement they have already been addressed. The U.S. FDA conducted the audit last month. (bit.ly/1RwOBQA)

Lupin also said it has recalled some products manufactured in Mandideep before 2015, but added there is no material financial impact from it.

U.S. and EU drug regulators have urged India's $15 billion pharmaceutical industry, dominated by Sun Pharmaceutical, Dr Reddy's Laboratories, Lupin and Cadila Healthcare, to improve manufacturing standards and ensure the reliability of data to maintain its dominance in the generic drugs industry.

Complaints from the regulators have ranged from issues over hygiene and maintenance to concerns over falsifying manufacturing-related tests results and data.

(Reporting by Krishna N. Das; Editing by Subhranshu Sahu)

[© 2016 Thomson Reuters. All rights reserved.]

Copyright 2016 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.