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Shilpa Medicare has received Form no 483 observations, related to SEZ formulation facilities situated at Jadcherla, Telangana, from the United States Food & Drug Administration (USFDA).
The company has received a total of 10 observations, out of which 7 observations are for improvement in procedures and practices and 3 observations are related to setting of analytical specifications, test procedures and method validation.
Shilpa, is involved in the manufacturing of active pharmaceutical ingredients (APIs) since 1987; overtime the company shifted its focus to formulation targeting regulated markets.
Further, Shilpa Medicare needs to reply to USFDA, within a period of 15 days, with a plan for corrective action.
