USFDA issues 10 observations to Shilpa Medicare’s Telangana facility

05 Dec 2017 Evaluate

Shilpa Medicare has received 483 observations from the United States Food & Drug Administration (USFDA) in relation to SEZ Formulation Facilities situated at Jadcherla, Telangana (near Hyderabad). Total 10 observations were cited during the close up meeting. Out of total 10 observations, 7 observations are improvement in procedures and practices and remaining 3 observations are related to setting of analytical specifications, test procedures and method validation.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.


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