17:59 IST
NSE
Regulatory Approval
Lupin Regulatory Approval
Lupin received U.S. FDA approval for Sodium Zirconium Cyclosilicate for Oral Suspension. The drug treats hyperkalemia in adults.
Lupin Ltd
Lupin Ltd news stories on ALFA NewsRead the news →- Share price
- ₹2,006.90
- Market cap
- ₹91,774 Cr
- Revenue (annual)
- ₹27,958 Cr
- Net profit (annual)
- ₹5,333 Cr
- P/E (TTM)
- 16.6×Sector 47.4×
- Promoter holding
- 46.85%-0.01% QoQ
- FII holding
- 22.42%Current quarter
Reference market data from a third-party provider, updated daily. Not a valuation or a recommendation.
Announcement type
All
Regulatory Approval 10Other Announcement 7Employee Stock Options 7Earnings Call 5Product Launch 4Financial Results 4Merger & Restructuring 3Business Update 3Annual General Meeting 3Partnership 2Management Change 2Results Update 1Legal & Regulatory 1Dividend 1Board Meeting Outcome 1Board Meeting Date 1
Time
10 announcements with these filters
09:38 IST
NSE
Regulatory Approval
Lupin Regulatory Approval
Lupin received tentative U.S. FDA approval for Enzalutamide Tablets. The approval covers strengths of 40mg, 80mg, 120mg, and 160mg.
22:59 IST
NSE
Regulatory Approval
Lupin Regulatory Approval
Lupin received U.S. FDA approval for Ranluspec, an interchangeable biosimilar for Lucentis. This milestone expands the company's ophthalmology portfolio in the American market.
11:01 IST
NSE
Regulatory Approval
Lupin Regulatory Approval
Lupin and Natco received U.S. FDA approval for Eribulin Mesylate Injection. The reference drug has estimated annual U.S. sales of ₹415.15 Crore.
- Value
- ₹415.1 Cr
19:03 IST
BSE
Regulatory Approval
Lupin Regulatory Approval
Lupin received U.S. FDA approval for its Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride tablets. The product targets a USD 132.8 million market.
- Value
- ₹1,262 Cr
- Execution
- 180-day generic drug exclusivity
15:48 IST
NSE
Regulatory Approval
Lupin Regulatory Approval
Lupin received Chinese regulatory approval for Oseltamivir Phosphate Oral Suspension, marking its first product entry into China. This milestone strengthens its global footprint in paediatric care.
21:08 IST
NSE
Regulatory Approval
Lupin Regulatory Approval
Lupin received tentative U.S. FDA approval for Revefenacin Inhalation Solution, targeting a USD 260.7 million market. This strengthens Lupin's respiratory portfolio in the United States.
- Value
- ₹2,503 Cr
18:26 IST
NSE
Regulatory Approval
Lupin Regulatory Approval
Lupin received US FDA approval for Famotidine Injection, targeting an $8.7 million market. This ₹82.65 Crore opportunity strengthens its presence in the US gastrointestinal segment.
- Value
- ₹82.65 Cr
09:08 IST
BSE
Regulatory Approval
Lupin Regulatory Approval
Lupin Limited received U.S. FDA approval for Glycerol Phenylbutyrate Oral Liquid, a bioequivalent version of Ravicti. The reference product had annual U.S. sales of approximately ₹3201.50 Crore (USD 337 million) in 2025. The drug is indicated for chronic management of urea cycle disorders, strengthening Lupin's specialty generic portfolio in the U.S. market.
- Value
- ₹3,202 Cr
17:20 IST
NSE
Regulatory Approval
Lupin Regulatory Approval
Lupin Limited received U.S. FDA approval for its generic Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, bioequivalent to Xigduo® XR. The company also secured tentative approval for a 2.5 mg/1,000 mg variant. This regulatory milestone enables Lupin to market the anti-diabetic medication in the United States, expanding its metabolic therapy portfolio.