Pharmaceutical major Cipla has on June 10 received the establishment inspection report (EIR) from the USFDA for its Kurkumbh manufacturing site in Maharashtra.
The site, which consisted of three units, was inspected by the USFDA from March 11 to March 20, this year. Receipt of EIR indicates closure of the inspection.
The Kurkumbh site manufactures active pharmaceutical ingredients (API) and formulations and is one of the four sites that the company operates. Many of the company's pipeline products filed in the US market, come from this facility.
The audit was triggered as part of routine Good Manufacturing Practices (GMP) inspection, and also for a specific product filed in the US-based on novel technology slated for approval beyond 2024
The drugmaker was issued eight observations for GMP and 10 observations for pre-approval inspection (PAI).
Shares of Cipla rose 0.52 percent and were trading at Rs 552.45 on BSE at 3.20 pm, the benchmark Sensex gained 0.47 percent to 39,803.52 points.
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