Morepen Labs Secures China’s NMPA Approval for Loratadine Export

1 Apr 2025 , 02:22 PM

Morepen Laboratories Ltd. announced April 1 that it has received a green signal from China’s Center for Drug Evaluation (CDE) at the National Medical Products Administration (NMPA) for the export of Loratadine. Loratadine is a commonly prescribed second-generation antihistamine drug for the treatment of allergic diseases including allergic rhinitis and chronic urticaria.

With this approval, Morepen Laboratories aims to strengthen its presence in China, which is one of the world’s largest pharmaceutical markets. Morepen currently holds an 80% market share in the US generics market for Loratadine, making it a key global player in this segment.

The company has been exporting APIs to the US for over 25 years, with its API exports alone valued at ₹650 crore. “The approval from China’s NMPA is a testimony to the company’s focus on quality with regulatory excellence and global footprint,” said Kushal Suri, Director – Sales & Marketing at Morepen Laboratories.

China is identified as a key growth market, and this milestone will help Morepen will leverage this milestone to cater to the climbing demand for quality antihistamine and anti-allergy APIs.

Morepen is one of the largest suppliers of Loratadine, Montelukast, Desloratadine, Atorvastatin, Rosuvastatin and Fexofenadine with an extensive API exporting base from India. The company manufactures and exports API to 82 countries across the globe, manufacturing 144MTPA of APIs.

Morepen has world-class USFDA approved manufacturing facilities at Masulkhana and Baddi, Himachal Pradesh. The company is catering to regulated and emerging markets like the US, Europe, Japan, China, and Russia.

Its Intellectual property (IP) portfolio comprises of 167 patents, 27 US Drug Master Files (USDMFs), 12 Certificates of Suitability (CEPs), 10 China Import Drug Licenses (IDLs), 278 Drug Master Files (DMFs), and 44 new products under development.

Since 1993, Morepen has been manufacturing Loratadine and is the first Indian company to produce this molecule. Over the years, Morepen has established itself as a trusted pharmaceutical manufacturer by receiving approvals from the world’s top regulatory bodies, including the USFDA.