The USFDA has inspected Shilpa Medicare’s Analytical Services Division situated at Unit 7, Nacharam, Hyderabad, Telangana during March 08, 2023 to March 10, 2023. This is a full GMP inspection. The inspection is closed with 2 minor observations, which are related to improvements in existing procedures and are addressable.
The Company will be submitting the responses to USFDA observations within stipulated timeline and will work towards implementing the corrective actions to address the observations. This is the second USFDA inspection on the site. The initial inspection was done during April 2022, for which the GMP clearance (EIR) was issued in July 2022.
The facility is involved in analytical testing of drug products, drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers and conduct of other miscellaneous studies. This facility is involved in the testing of US/EU & other markets commercial batches.
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.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
| View more.. | |
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