Drug-maker Ipca Laboratories has said that there will be no finished drug exports from its Madhya Pradesh plant to the US, till it resolves certain “non-conformances” that it noticed and referred to the US regulatory authority.
The facility, making oral solid dosage finished medicines, is located in the Pharmazone, Special Economic Zone in Indore. The company’s stock price was down 4.6 per cent to Rs 437 at 12.30 p.m., following the announcement on Thursday.
With reference to an earlier announcement, regarding US Food And Drug Administration (FDA) approval for Indore formulations manufacturing facility -- the US-FDA, following an inspection, had found acceptable the company's oral solid dosage formulations facility at Indore, the company said.
However, during the course of an internal quality assurance review, the company noticed a few non-conformances at the said manufacturing unit, it told the Bombay Stock Exchange.
“The company has voluntarily referred these to the US-FDA and the same is under discussion with them for an appropriate resolution.
Till such time this issue is resolved to the satisfaction of the US-FDA, no dosage formulations manufactured at this manufacturing unit will be commercialised for the US market,” the company said.
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