Morepen Laboratories secures 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 API, Loratadine.

With an 80 per cent market share in the US, Morepen aims to strengthen its position as a leading exporter of Loratadine in international markets. Loratadine is a prescribed second-generation antihistamine and anti-allergy drug used to treat allergic symptoms such as hay fever and chronic urticaria.

Currently, the company exports six APIs to 82 countries, with its API exports valued at ₹650 crore.

Commenting on the expansion, Kushal Suri, Director – Sales & Marketing, Morepen Laboratories, said, “China represents a vast growth opportunity, and this expansion will allow us to meet the increasing demand for high-quality antihistamine and anti-allergy APIs.”

Founded in 1984, Morepen has manufacturing facilities in Masulkhana and Baddi, India. The company continues its expansion efforts across regulated and emerging markets, including the US, Europe, Japan, China, and Russia. Morepen holds 167 patents, 27 US DMFs, 12 CEP filings, 10 China IDLs, 278 other DMFs, and 44 new products in its portfolio.