1. Another attack on Indian generic Pharmaceutical sector?
The U.S. drug regulator, FDA has now sent a “warning letter” to Indian pharma company Lupin ltd for Poor Manufacturing Practices and using adulterated APIs.
Company has now suspended production at the facility.
The U.S. drug regulator, FDA has now sent a “warning letter” to Indian pharma company Lupin ltd for Poor Manufacturing Practices and using adulterated APIs.
Company has now suspended production at the facility.
2. Lupin is a major Pharmaceutical manufacturing company producing both generic and branded medicines, APIs, biosimilars (drugs similar to approved drugs) and has 15 plants in India, the US, Brazil and Mexico.
3. Warning letter from US drug regulator to Lupin Tarapur plant accuses them of
• Violations of poor manufacturing practices,
• Problems with claims for what a product can do and
• Incorrect directions for use.
fda.gov
• Violations of poor manufacturing practices,
• Problems with claims for what a product can do and
• Incorrect directions for use.
fda.gov
4. FDA says that Lupin had not established written procedures for cleaning equipment for manufacturing APIs.
They also don’t have written procedures to monitor progress of “processing steps” among other things.
thewire.in
They also don’t have written procedures to monitor progress of “processing steps” among other things.
thewire.in
5. Lupin had replied to the warning letter which was first issued privately in September but FDA found it lacking.
“Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.”
“Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.”
6. But strangely in a surprising move the FDA made the “warning letter” public just two weeks after WHO -without proof linked the death of children in Gambia with cough syrup manufactured in India.
For now FDA withholds new approvals & listings for Lupin and no exports. 🤔
For now FDA withholds new approvals & listings for Lupin and no exports. 🤔
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