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 anti-allergy API, Loratadine. This milestone marks a significant step in Morepen’s strategic expansion into one of the world's largest pharmaceutical markets.
Currently holding an over 80% market share in the US generics market for Loratadine, Morepen has established itself as the leading global manufacturer of the second-generation antihistamine. With more than 25 years of successful exports to the US, the company’s API exports are valued at approximately Rs. 650 crores. The Chinese approval further cements Morepen’s dominance in the global pharmaceutical landscape, positioning the company to capture a substantial share of the Chinese market.
Strategic Expansion into China
Kushal Suri, Director of Sales & Marketing at Morepen Laboratories, remarked, “The NMPA approval is a testament to Morepen’s commitment to quality, regulatory excellence, and global market leadership. China offers immense growth opportunities, and this achievement enables us to meet the increasing demand for high-quality antihistamine and anti-allergy APIs, further solidifying our position in global healthcare.”
Morepen Laboratories is India’s leading API exporter for six major products, including Loratadine, Montelukast, Desloratadine, Atorvastatin, Rosuvastatin, and Fexofenadine. With exports to 82 countries, the company maintains a robust manufacturing capacity of 144 metric tons of API annually.
Operating from world-class manufacturing facilities in Masulkhana and Baddi, both approved by the USFDA, Morepen continues to expand its reach across regulated and emerging markets, including the US, Europe, Japan, China, and Russia. The company’s impressive portfolio includes 167 patents, 27 US Drug Master Files (USDMFs), 12 Certificates of Suitability (CEPs), 10 China IDLs, 278 other DMFs, and 44 new products. Notably, Loratadine is backed by approved USDMF, CEP, and IDL China registrations, along with 23 additional DMFs and three granted patents.
With this strategic expansion into China, Morepen Laboratories is set to further reinforce its leadership in the global pharmaceutical sector.