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  • 12 Jun 2025
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India's Morepen secures approval of anti-allergy API Loratadine for export to China

Overview

India-based Morepen Laboratories, a global leader in Active Pharmaceutical Ingredient (API) manufacturing, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for its Loratadine (anti-allergy API). This marks a significant milestone in Morepen’s strategic entry into one of the world’s largest pharmaceutical markets.

The market shares for Loratadine in US

• Morepen commands an over 80% market share in the US generics market for Loratadine, making it the undisputed leader in its category. 

• The company has been exporting to the US market for over 25 years, its API exports alone are valued at Rs 650 crore. 

Morepen Strengthens Global Leadership in Loratadine Market

• Approval reinforces Morepen’s dominance as a leading global manufacturer of Loratadine.
• Loratadine, a second-generation antihistamine, is widely used for hay fever & chronic urticaria.
• The development positions Morepen to capture a significant share of the Chinese market.
• Enhances Morepen’s global presence in the pharmaceutical sector.

Statement from Kushal Suri from Morepen Laboratories

Kushal Suri, Director – Sales & Marketing, Morepen Laboratories said, “China represents a vast growth opportunity, and this milestone will allow us to meet the increasing demand for high-quality antihistamine and anti-allergy APIs while reinforcing our leadership in global healthcare.”

Morepen’s API exporter

• Morepen is a leading APIs exporter out of India for six leading products, including Loratadine, Montelukast, Desloratadine, Atorvastatin, Rosuvastatin, and Fexofenadine. 

• The company exports to 82 countries and has a manufacturing capacity of 144 metric tons API annually.

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