Lupin Limited has clarified reports regarding a recent news item about the company receiving US FDA approval. The company confirmed that it has received tentative approval from the US FDA for its generic equivalent of Janumet® Tablets (Sitagliptin and Metformin Hydrochloride Tablets) in strengths of 50 mg/500 mg and 50 mg/1000 mg. These tablets are a generic version of the diabetes medication manufactured by Merck Sharp & Dohme LLC.
Key Highlights from the Clarification
- Approval Details:
- Lupin received tentative approval for Janumet’s generic equivalent.
- The approval enables Lupin to market this drug as a treatment for Type-2 Diabetes.
- Regulatory Disclosure:
- The company stated that this event was not material under Regulation 30 of SEBI’s Listing Obligations and Disclosure Requirements Regulations (2015).
- Hence, the information was not disclosed to the stock exchanges earlier.
- Stock Movement Explanation:
- Lupin confirmed that it is unaware of any specific information that could explain the movement in its stock price following this news.
- Impact on the Company:
- Lupin clarified that there is no material financial or operational impact of this approval on the company at present.
Lupin assured stakeholders that it complies with SEBI regulations and will promptly disclose any information deemed material in the future.
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