BusinessMorepen Laboratories Files First US ANDA for Sitagliptin Tablets
Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the US FDA for sitagliptin tablets in 25 mg, 50 mg, and 100 mg strengths. This marks Morepen's entry into integrated finished-dose development and regulatory filings, expanding its capabilities beyond API and CDMO services. Sitagliptin is a DPP-4 inhibitor used to treat type 2 diabetes, with the innovator product Januvia generating $1.6 billion in sales in 2025.
Business Standard·2h ago



