The United States Food and Drug Administration (USFDA) has inspected Shilpa Medicare’s recently started Analytical Services Division situated at Hyderabad, Telangana during April 26, 2022 to April 29, 2022.
The inspection was triggered by the company’s submission of applications for four ANDA’s to seek approval to use this site as alternate testing laboratory. The inspection has been closed with four observations, which are related to improvements in existing procedures and are addressable. The company will be submitting the responses to US FDA observations within stipulated timeline and implement the corrective actions to address the observations.
This Analytical Services Division has started analytical testing operations from May 2021. This is the first US FDA inspection of this facility. 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 has not been used till now to test products for commercial dispatch into US/EU markets.
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. | 1849.05 |
Dr. Reddys Lab | 1274.25 |
Cipla | 1553.20 |
Lupin | 2184.00 |
Zydus Lifesciences | 1001.85 |
View more.. |