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| Exchange Disseminated Time 02/07/2016 17:25:49 | FDC Ltd has informed BSE that
1. Inspection of the Company's manufacturing unit situated at Waluj, District- Aurangabad, Maharashtra, by US Food and Drug Administration (US FDA) has been completed on July 01, 2016. The US FDA has made two minor observations for which appropriate steps shall be taken by the Company.
The above audit was carried out in relation to cGMP inspection and ANDA filed by the Company for product Dorzolamide Ophthalmic Solution.
2. Further, the Company has also received the Establishment Inspection Report (EIR) from US FDA for its manufacturing unit situated at Baddi, Himachal Pradesh with "No observations". This approval confirms the closure of inspection conducted in February' 2016. The said audit was carried out in relation to cGMP inspection and ANDA filed by the Company for product Cefixime 400 mg tablet. |
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