Morepen Laboratories Gets Approval for Loratadine API in China

Morepen Laboratories Limited has received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its anti-allergy Active Pharmaceutical Ingredient (API), Loratadine. The approval marks a significant milestone in the company’s growth strategy, as it continues to expand its global footprint.

Strengthening Global Market Leadership

With an 80% market share in the US, Morepen aims to strengthen its position as a leading exporter of Loratadine in international markets, especially in China, which offers a vast growth opportunity. Doctors widely prescribe Loratadine, a second-generation antihistamine and anti-allergy drug, for treating allergic symptoms such as hay fever and chronic urticaria.

Expanding Export Portfolio

Currently, Morepen exports six APIs to 82 countries, with API exports valued at ₹650 crore. This new approval in China will enable the company to cater to the increasing demand for high-quality antihistamine and anti-allergy APIs, further bolstering its presence in the global pharmaceutical market.

Global Manufacturing and Market Presence

Morepen Laboratories operates manufacturing facilities in Masulkhana and Baddi, India, and continues to expand across regulated and emerging markets, including the US, Europe, Japan, China, and Russia. The company holds a strong intellectual property portfolio, including 167 patents, 27 US Drug Master Files (DMFs), 12 CEP filings, 10 China IDLs, 278 other DMFs, and 44 new products. As reported by thehindubusinessline.com, the expansion further solidifies Morepen’s commitment to meeting the needs of international markets with high-quality pharmaceutical products.