Regulatory29 Sep 2026 · Mon
MOREPENLABMorepen Laboratories
Morepen files its first US generic drug application, for diabetes drug sitagliptin
Morepen Laboratories submitted its first abbreviated new drug application (ANDA) to the US FDA, for sitagliptin tablets in three strengths.
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- Sector
- Pharma
What happened
- Morepen Laboratories submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration for sitagliptin tablets in 25 mg, 50 mg and 100 mg strengths.
- It is the company's first ANDA. Morepen has mainly made active pharmaceutical ingredients and done contract development and manufacturing.
- The company expects 24 to 36 months from submission to possible approval and launch, depending on the FDA's review, facility inspections and patent or exclusivity issues.
Why it matters
Good to know: An ANDA is the application a company files to sell a generic copy of a medicine in the US. Sitagliptin is used to treat type 2 diabetes.
Key facts
- Drug
- Sitagliptin tablets, 25/50/100 mg
- Regulator
- US FDA
- Expected timeline
- 24–36 months to possible approval
Read the source
This is a summary of public news about Morepen Laboratories, for information only. It is not a recommendation to buy, sell or hold MOREPENLAB.
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