Natco Pharma says USFDA clears inspection of its chemical division unit in Chennai
The USFDA released a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed
New Delhi: Drug firm Natco Pharma has received the Establishment Inspection Report for its chemical division facility in Chennai from the US health regulator after closure of inspection.
"Natco Pharma is pleased to announce receipt of successful Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the inspection conducted, during the period 8 February to 12 February, 2016, at its Chemical Division, Chennai, India," the company said in a BSE filing.
The USFDA released a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed.
In a separate filing, the company said the US Patent and Trademark office (PTO) has ruled in favour of its marketing partner Mylan in its inter parties review proceedings and found all claims of two related Copaxone 40 mg/mL patents to unpatentable.
Shares of Natco Pharma were trading at Rs 687 apiece, up 4.85 percent, from their previous close on the BSE.
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