Morepen Laboratories Limited, a global leader in Active Pharmaceutical Ingredient (API) manufacturing, has received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its Loratadine API. This milestone strengthens Morepen’s entry into China, one of the world’s largest pharmaceutical markets.
Morepen dominates over 80% of the US generics market for Loratadine, a widely used second-generation antihistamine for allergies, chronic urticaria, and hay fever. With API exports valued at ₹650 crores, the company has been a trusted supplier in the US for over 25 years. The latest approval positions Morepen to capture a significant share of China’s growing pharmaceutical sector while reinforcing its global leadership.
The company is India’s top exporter of six leading APIs, including Loratadine, Montelukast, Desloratadine, Atorvastatin, Rosuvastatin, and Fexofenadine. With a manufacturing capacity of 144 metric tons annually, Morepen exports to 82 countries. Its world-class manufacturing facilities in Masulkhana and Baddi are USFDA-approved, ensuring compliance with stringent global quality standards.
Morepen holds 167 patents, 27 USDMFs, 12 CEP filings, 10 China IDLs, and 278 other DMFs, showcasing its strong research and regulatory portfolio. With Loratadine already approved under USDMF, CEP, and IDL China, Morepen continues to expand its footprint across key markets like the US, Europe, Japan, China, and Russia.
