Zydus Secures NMPA Clearance for Venlafaxine Generic

Zydus Secures NMPA Clearance for Venlafaxine Generic

India Pharma Outlook Team | Wednesday, 12 November 2025

 Zydus Lifesciences

Zydus Lifesciences has been granted consent by the National Medical Products Administration (NMPA) of China on its generic form of Venlafaxine Extended-Release capsules that is applied in the treatment of depressive and anxiety disorders.

This is the first marketing approval that this company has received in China, and this is major milestone because this company is venturing in one of the pharmaceutical market in the world.

Venlafaxine ER which is an approved medication is prescribed to treat Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), Social Anxiety Disorder (SAD) and Panic Disorder (PD).

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It operates by replacing the lack of serotonin and norepinephrine in the brain to aid in improving mood and lessens the symptoms of anxiety. The product will be produced at the location of Zydus Moraiya in Ahmedabad an important location in its global formulations business.

This approval gives Zydus Lifesciences a stronger presence in the international market and provides the firm with a new growth opportunity in the growing generic drugs market in China. The relocation is part of the company in its active diversification of its portfolio beyond India and the US to exploit areas that are experiencing increased demand to access affordable mental health services.

The approval does not imply that Zydus can now enter the market but the fact is that Zydus is one of the handful of Indian pharmaceutical firms to have received regulatory clearance by the NMPA. The fact that the Chinese market is sensitive to the price and quality of generics is also in line with the long-term strategy of Zydus to provide affordable healthcare worldwide. This achievement supports Zydus Lifesciences in terms of expansion of its operations in international markets and promotion of therapies that will treat depressive disorders all over the world.

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