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Drug maker Sun Pharmaceutical Industries has received a reprieve on regulatory issues facing Caraco, its wholly-owned subsidiary in the US.
The US Food and Drug Authority (USFDA) has said that Caraco could resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Michigan, Sun said.
This follows inspections earlier this year and corrective action on issues raised by the USFDA that found Caraco in compliance with “relevant paragraphs of the Consent Decree”, the company said, without giving details.
With reference to other requirements of the same Consent Decree, Caraco is required to now work with an external auditor conducting regular inspections for an extended period, Sun added.
In June 2009, the US health regulator had seized drugs manufactured at Caraco due to unresolved violations of the Good Manufacturing Practices norms. Caraco entered into a Consent Decree with the FDA in September 2009.
Under the terms of the decree, Caraco had to stop manufacturing products till the company received written notification from independent experts and the FDA that it was in compliance with the Consent Decree and regulations and could resume operations, Sun said.
Two off the block
Two products from the Caraco stable have emerged from the regulatory shadow, Sun said.
“During their inspection, the USFDA reviewed the certification reports for production of Carvedilol USP as well as Paramomycin USP, and subsequently reviewed corrective actions on 483's. Currently, Caraco may resume products of only these two products.”
In a 483, observations are made, and a company is let off the hook if it takes preventive measures.
But if the concerns persist over safety, efficacy and quality of the drugs coming into the US, a warning letter is issued.
Manufacturing of other products from these sites, including those pending approval with the USFDA, will be subject to similar rigorous approval procedure, Sun said.
The increase in production at these sites and resultant revenue contribution is expected to be gradual, it added.
Sun shares were up 2 per cent on the BSE, at Rs 681 on Tuesday.
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