Zydus Lifesciences Gains NMPA Approval for Venlafaxine ER Capsules, Production to Ramp Up at Ahmedabad Facility

Zydus Lifesciences Limited has announced receiving approval from China’s NMPA for its Venlafaxine Extended-Release (ER) Capsules, available in 75 mg and 150 mg strengths. These capsules are used to manage mental health disorders, including major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder, by balancing serotonin and norepinephrine levels.

The production of this drug will take place at Zydus’s manufacturing facility at Moraiya, Ahmedabad. This approval marks the first from China’s stringent regulatory body for this product line within the Zydus Group and significantly enhances the company’s footprint in the vital Chinese pharmaceutical market.

Venlafaxine ER Capsules will complement Zydus’s strong global portfolio of approved drugs, including prior approvals from USFDA, and support ongoing efforts to address growing global mental health challenges. The company leverages advanced manufacturing capabilities ensuring the highest quality standards for supply across international markets.

This milestone reflects Zydus Lifesciences' commitment to innovation, quality, and global expansion.

Key Highlights:

Zydus Lifesciences receives China’s NMPA approval for Venlafaxine ER Capsules (75 mg & 150 mg)​

Capsules indicated for treatment of major depression and anxiety disorders​

Manufacturing at Moraiya facility, Ahmedabad enhances production capabilities​

First approval from China for Zydus in this product segment; strengthens global presence​

Complements USFDA approvals and reinforces mental health product portfolio​

Sources: Zydus Lifesciences NSE Filing, National Medical Products Administration China, Economic Times, Times of India