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Indoco Remedies declines 2% as USFDA issues 4 observations for Goa plant

The US Food and Drug Administration (USFDA) conducted audit at company's sterile manufacturing facility in Verna, Goa (Plant II) from May 27, 2019 to June 4, 2019.

June 06, 2019 / 12:08 PM IST
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Share price of Indoco Remedies shed 2.5 percent intraday Thursday after USFDA issued 4 observations post inspection at Goa facility.

The US Food and Drug Administration (USFDA) conducted audit at company's sterile manufacturing facility in Verna, Goa (Plant II) from May 27, 2019 to June 4, 2019 and issued 4 observations (483s), as per BSE release.

These observations are procedural in nature, not pertaining to data integrity. The company will submit its responses shortly, it added.

Aditi Kare Panandikar, Managing Director at Indoco Remedies said, "The recent USFDA inspection was a scheduled PAI, i.e., Prior Approval Inspection for Injectable products, filed from this facility. We are hopeful for an early and successful closure of this audit, which will expedite approvals of the pending ANDAs."

At 11:53 hrs Indoco Remedies was quoting at Rs 177.00, down Rs 2.50, or 1.39 percent on the BSE.

Moneycontrol News
first published: Jun 6, 2019 12:06 pm

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