Lupin says it sees no supply disruption at plant despite
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[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.
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(Reporting by Krishna N. Das; Editing by Subhranshu Sahu)
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