‹ All Posts
Shrikant Pandey

14 mins ago · SEBI Registration INH000023986

MOREPEN LABORATORIES: LAUNCHES FIRST U.S. PRESCRIPTION

MOREPEN LABORATORIES: LAUNCHES FIRST U.S. PRESCRIPTION GENERIC DRUG, DESLORATADINE TABLETS MOREPENLAB - Product Launch: Launched Desloratadine Tablets USP 5 mg in 100-count and 500-count packs for the U.S. market. - U.S. Subsidiary: The launch is being undertaken through its wholly owned U.S. subsidiary, Morepen Bio Inc. - Strategic Expansion: Builds on Morepen’s established Desloratadine API supply to the U.S., marking its entry into finished-dosage generics. - ANDA Pipeline: Filed its first ANDA with the U.S. FDA for Sitagliptin Phosphate Tablets USP in 25 mg, 50 mg and 100 mg strengths. The application is currently under regulatory review. - Future Plans: The company intends to pursue additional U.S. prescription generic filings and may explore opportunities in high-potency APIs and oncology. Impact: Positive – The launch marks a strategic move up the value chain, expanding Morepen’s presence from API supply into U.S. finished-dosage generics and creating an additional potential revenue stream alongside its CDMO business.

#WatchOutFor
2 likes·2 comments