Morepen Laboratories Limited, 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.

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 crores.

This approval further solidifies Morepen’s position as the dominant global manufacturer of Loratadine, a widely prescribed second-generation antihistamine and anti-allergy drug used to treat allergic symptoms such as hay fever and chronic urticaria.

With this development, Morepen is poised to capture a significant share of the Chinese market while reinforcing its standing in the global pharmaceutical landscape.

“The approval by China’s NMPA is a testament to Morepen’s unwavering commitment to quality, regulatory excellence, and global market expansion,” said Kushal Suri, Director – Sales & Marketing, Morepen Laboratories. “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 is the number one 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.

The company holds 167 patents; 27 USDMFs; 12 CEP filings; 10 China IDLs; 278 other DMFs, and 44 new products in its portfolio. Loratadine also holds approved USDMF, CEP, and IDL China registrations, along with 23 additional other DMFs and three granted patents.