The active pharmaceutical ingredients manufacturing unit at Madad of Kopran Research Laboratories, a subsidiary of Kopran, was inspected by the US FDA between January 21 and 25. The inspection was completed without issuance of any observation under Form 483, Kopran said, and added this will facilitate the commencement of supplies of APIs to the US once the DMFs are filed and approved. Kopran has filed the DMF of Atenolol, which is already reviewed and active.
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