Morepen Laboratories Ltd. on Tuesday, April 1, said that it has received regulatory approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the export of Loratadine, which is used to treat allergic conditions such as hay fever and chronic urticaria.

This paves the way for Morepen to strengthen its footprint in one of the world’s largest pharmaceutical markets- China, Morepen Laboratories said in a stock exchange filing.

Loratadine, a widely prescribed second-generation antihistamine, is commonly used to treat allergic conditions such as hay fever and chronic urticaria. Morepen commands an impressive over 80 % market share in the US generics market for Loratadine, holding its position as the leader in this category. The company has been exporting to the US for over 25 years, with API exports alone valued at ₹650 crore, the filing added.

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

Following the announcement, shares of Morepen Lab rose 3% to touch an intraday high of ₹49.30 apiece on the BSE.

Morepen is the leading API exporter from India for six major products, including Loratadine, Montelukast, Desloratadine, Atorvastatin, Rosuvastatin, and Fexofenadine. The company exports to 82 countries worldwide and boasts a manufacturing capacity of 144 metric tons of APIs annually.

With world-class manufacturing facilities at Masulkhana and Baddi in Himachal Pradesh—both USFDA-approved—Morepen continues to expand across regulated and emerging markets, including the US, Europe, Japan, China, and Russia. The company holds an extensive portfolio of 167 patents, 27 US Drug Master Files (USDMFs), 12 CEP filings, 10 China IDLs, and 278 other DMFs, along with 44 new products in development.

Morepen has been at the forefront of Loratadine production since 1993, becoming the first Indian company to manufacture the molecule. Over the years, the company has earned a reputation for quality, innovation, and regulatory compliance, securing approvals from major global authorities, including the USFDA.

Shares of Morepen Laboratories were trading 2.57% higher at ₹49.08 on the BSE around 10 am.