Business · Companies · 13 hrs ago
Morepen launches first prescription generic in the US
Morepen Laboratories has launched its first US prescription generic, desloratadine tablets in a 5 mg strength.
The Indian company is selling the tablets in 100-count and 500-count packs through its wholly owned US subsidiary, Morepen Bio Inc.
The launch takes Morepen beyond supplying drug ingredients into making and distributing finished medicines in the United States.
Morepen had already introduced over-the-counter products there and has supplied the active ingredient for desloratadine to the US market for several years.
Its sitagliptin tablet application is under FDA review, with proposed strengths of 25 mg, 50 mg and 100 mg.
Morepen plans to pursue further US generic filings and distribution opportunities, using its existing ingredient and research capabilities; it may also assess high-potency ingredients and oncology products, subject to feasibility, regulation and market conditions.
Morepen Laboratories has launched its first prescription generic in the US, Desloratadine Tablets USP, 5 mg.
The product is being introduced in 100-count and 500-count packs through Morepen Bio Inc., the company’s wholly owned US subsidiary.
The launch extends Morepen’s US business from supplying active pharmaceutical ingredients into finished-dose medicines and distribution.
The company has submitted an application for Sitagliptin Phosphate Tablets to the US Food and Drug Administration, where it is under regulatory review.
Morepen plans to pursue further US prescription generic filings and distribution opportunities.
- Who
- Morepen Laboratories, through its wholly owned US subsidiary Morepen Bio Inc.
- What
- It launched Desloratadine Tablets USP, 5 mg, its first US prescription generic.
- When
- Monday, November 9, 2026.
- Where
- The US market.
- Why
- The launch extends Morepen’s presence into finished-dose medicines and US distribution.
This story does not have two clearly opposing sides.
Morepen supplied Desloratadine active pharmaceutical ingredient to the US market.
Morepen introduced over-the-counter products in the US market.
Morepen submitted its first Abbreviated New Drug Application for Sitagliptin Phosphate Tablets to the FDA.
Morepen announced the launch of Desloratadine Tablets USP, 5 mg, in the US.
- Product
- Desloratadine Tablets USP, 5 mg
- Pack sizes
- 100-count and 500-count
- US subsidiary
- Morepen Bio Inc.
- Pending application
- Sitagliptin Phosphate Tablets, 25 mg, 50 mg and 100 mg strengths
- Regulator
- US Food and Drug Administration
What people are saying
Our long-standing API relationships in regulated markets provide a strong foundation for Morepen's next phase of growth.