Morepen Secures Chinese Market Entry with Loratadine Export Approval

Gurugram | April 1, 2025​

Morepen Laboratories Ltd. (NSE: MOREPENLAB | BSE: 500288) announced a key regulatory breakthrough as it secured approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), China, for the export of its anti-allergy API, Loratadine. This marks a pivotal step in the company's global expansion strategy and opens access to one of the world’s largest pharmaceutical markets.

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Key Highlights​

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Strategic Expansion into China​

“This approval by China’s NMPA is a testament to Morepen’s unwavering commitment to quality, regulatory excellence, and global market expansion,” said Kushal Suri, Director – Sales & Marketing, Morepen Laboratories.
He emphasized that China presents a vast growth opportunity, and the approval will enable the company to meet growing demand for high-quality antihistamine and anti-allergy APIs, while strengthening Morepen's position in global healthcare.

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Leadership in API Exports​

Morepen is India’s number one exporter of six leading APIs:

• Loratadine
• Montelukast
• Desloratadine
• Atorvastatin
• Rosuvastatin
• Fexofenadine

With two USFDA-approved facilities at Masulkhana and Baddi, Morepen continues to enhance its presence across regulated markets such as the US, Europe, Japan, and China, along with emerging regions like Russia.

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Regulatory & R&D Credentials​

• 167 patents
• 27 USDMFs
• 12 CEPs
• 10 IDLs (China)
• 278 other DMFs
• 44 new products in the pipeline

For Loratadine alone, the company holds approved USDMF, CEP, IDL China registrations, 23 other DMFs, and 3 granted patents.

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Legacy of Excellence in Loratadine​

Since 1993, when it became the first Indian manufacturer of Loratadine, Morepen has built a global reputation for consistent quality, innovation, and regulatory adherence. It now supplies the API to major pharmaceutical markets globally.

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About Morepen Laboratories Ltd.​

Founded in 1984, Morepen Laboratories is a diversified pharmaceutical player engaged in APIs, formulations, and medical devices. The company has installed over 12.33 million glucometers and sold 1.65 billion blood glucose strips, expanding its reach into India’s tier-2 and tier-3 cities.