Morepen Laboratories has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for its Loratadine active pharmaceutical ingredient (API). This regulatory clearance allows the company to enter the Chinese pharma market, one of the largest in the world. Morepen holds over 80 per cent market share in the US generics market for Loratadine and has been exporting to the US for over 25 years. The company’s API exports are valued at ₹650 crore. Loratadine, a second-generation antihistamine, is widely used for treating allergic symptoms such as hay fever and chronic urticaria.
Kushal Suri, Director – Sales & Marketing, Morepen Laboratories, said, “The 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.”
Morepen is India’s leading API exporter for six key products, including Loratadine, Montelukast, Desloratadine, Atorvastatin, Rosuvastatin, and Fexofenadine. The company exports to 82 countries and has an annual manufacturing capacity of 144 metric tons of API. With manufacturing facilities at Masulkhana and Baddi, both US FDA-approved, Morepen continues to expand its presence in regulated and emerging markets, including the US, Europe, Japan, China, and Russia. The company holds 167 patents, 27 USDMFs, 12 CEP filings, 10 China IDLs, 278 other DMFs, and 44 new products in its portfolio. Loratadine has approved USDMF, CEP, and IDL China registrations, along with 23 other DMFs and three granted patents. This approval strengthens Morepen’s position as a global supplier of antihistamine APIs and facilitates its expansion into the Chinese market.