Healthcare/Biotech
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Updated on 11 Nov 2025, 11:36 am
Reviewed By
Aditi Singh | Whalesbook News Team
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Zydus Lifesciences has achieved a significant milestone by receiving its first drug approval in China. The National Medical Products Administration (NMPA) has cleared Venlafaxine Extended-Release (ER) Capsules, available in 75 mg and 150 mg dosages. This medication is indicated for the treatment of various mood and anxiety disorders, including Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD). The drug functions by helping to rebalance serotonin and norepinephrine levels in the brain, thereby improving mood and alleviating anxiety. Production of these capsules will be carried out at Zydus' manufacturing plant located in Moraiya, Ahmedabad. This approval is a crucial step for Zydus in expanding its global footprint and tapping into the large Chinese pharmaceutical market. Additionally, Zydus recently completed clinical trials in China for Desidustat, a drug for anemia in Chronic Kidney Disease patients, and is preparing for its launch.
Impact: This approval is expected to positively impact Zydus Lifesciences' revenue streams and market presence in China. It validates the company's research and development efforts and its ability to navigate complex regulatory environments in major international markets. This could lead to increased investor confidence and potentially boost the company's stock performance. Rating: 8/10
Difficult Terms: - National Medical Products Administration (NMPA): The primary regulatory body in China responsible for approving drugs and medical devices for use within the country. - Venlafaxine Extended-Release (ER) Capsules: A specific formulation of the drug venlafaxine that releases its active ingredient slowly over a prolonged period. - Major Depressive Disorder (MDD): A mood disorder characterized by persistent sadness and loss of interest. - Generalised Anxiety Disorder (GAD): An anxiety disorder characterized by excessive worry about everyday things. - Social Anxiety Disorder (SAD): An anxiety disorder characterized by significant anxiety or fear in social situations. - Panic Disorder (PD): An anxiety disorder characterized by recurrent, unexpected panic attacks. - Serotonin and Norepinephrine: Neurotransmitters in the brain that play a crucial role in regulating mood, emotion, and stress response.