Pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and further to intimation dated October 19, 2023 about the pre-approval inspection (‘PAI’) conducted for the two drug product applications (ANDAs), by the United States Food and Drug Administration (‘USFDA’) at the Company’s Solid Oral Formulation facility (Plant I) located at Goa (‘Facility’) from October 12, 2023 to October 18, 2023, Indoco Remedies has informed that the Company had addressed the said observations comprehensively within the stipulated time, and has received Establishment Inspection Report (EIR) from USFDA, indicating successful closure of the said inspection. The PAI was conducted for two drug product applications (ANDAs) filed from this Facility, for which approvals are expected soon. The company has enclosed press release in this regard.
The above information is a part of company’s filings submitted to BSE.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1831.30 |
| Dr. Reddys Lab | 1307.00 |
| Cipla | 1361.00 |
| Zydus Lifesciences | 940.10 |
| Lupin | 2460.50 |
| View more.. | |
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