The Halol facility was placed under Import Alert by USFDA.
The company will submit an action plan on the observations and will engage with US FDA for next steps.
This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA
Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
The company had responded to the agency and carried out the required corrective actions.
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