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 The FDA found "significant violations" of current good manufacturing
practice (CGMP) regulations at Strides Pharma's plant in Puducherry
in southern India, the drug regulator said in a warning letter
(https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019)
that was made public on Tuesday.
Shares of the Bangalore-based company, which fell as much as 8% to a
near one-year low earlier on Wednesday, were trading down 3.2% at
0757 GMT.
Last month, Aurobindo Pharma Ltd was warned (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharma-limited-577033-06202019)
by the FDA for ignoring impurities in an active ingredient it
produced. Hyderabad-based Aurobindo recalled contaminated valsartan
in January and in March.
The destruction of quality-control paperwork by Strides and a lack
of adequate documentation that its medicines are safe "raise
questions about the effectiveness" of Strides's quality unit "and
the integrity and accuracy" of its data, said Francis Godwin,
director of the FDA's Office of Manufacturing Quality, in the
letter.
The regulator said an investigator found a binder containing CGMP
records, including batch records for U.S. drug products, discarded
with other records in a 55-gallon drum in Stride's scrap yard.
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"CGMP documents in the binder were dated as recently as January 21,
2019: seven days before our inspection. Your quality unit did not
review or check these documents prior to disposal," Godwin said in
the letter, addressed to Strides Chief Executive Officer Arun Kumar.
On July 2, Strides shares slumped after it said it received a
warning letter from the U.S. FDA, it did not disclose the content of
the letter at that time.
A Strides spokesman said on Wednesday the company won't be making
any further comments.
Strides bought a unit of Vivimed Labs Ltd in January. Vivimed
manufactures losartan, a drug that is part of a wider recall in the
United States.
The FDA's warning letter dated July 1 comes months after several
Indian drugmakers including Sun Pharmaceutical Ltd and Dr.Reddy's
Laboratories Ltd were named in a U.S. lawsuit against Israeli
drugmaker Teva Pharmaceutical Industries Ltd accusing it of
conspiring to inflate drug prices and stifle competition for generic
drugs.
(Reporting by Chandini Monnappa in Bengaluru; editing by Gopakumar
Warrier)
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