Bajaj Healthcare Secures DCGI Approval for Pimavanserin Manufacturing in India

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Mumbai, 30th January 2025 – Bajaj Healthcare Limited (NSE: BAJAJHCARE) has received approval from the Drug Controller General of India (DCGI) to manufacture both the Active Pharmaceutical Ingredient (API) and the Drug Formulation of Pimavanserin, a 34 mg capsule. The company has also extended manufacturing offers to several leading Indian pharmaceutical firms to ensure domestic market availability.

Key Highlights:

AspectDetails
Drug ApprovedPimavanserin (34 mg capsule)
Therapeutic UseTreatment of hallucinations and delusions in Parkinson’s disease psychosis
Global MarketSold under the brand NUPLAZID®, a preferred treatment in the US antipsychotic segment
Projected Sales (2025)Acadia Pharmaceuticals expects NUPLAZID® and DAYBUE™ to generate over $1 billion in net sales
Indian Market StrategyOffers extended to Indian pharma companies for local distribution.
Company ExpertiseManufacturing APIs, intermediates, formulations & nutraceuticals

Management Commentary

"The approval marks a major milestone for Bajaj Healthcare," said Anil Jain, Managing Director of Bajaj Healthcare Limited. "The success of NUPLAZID® in the US underscores the global demand for this innovative therapy. We are confident that its introduction in India will be a transformative advancement in the antipsychotic segment. This move further solidifies our presence in the CNS (Central Nervous System) market and reflects our commitment to advancing healthcare solutions in India."
The company reassured that its strong manufacturing capabilities will ensure that API and final drug formulations meet international quality standards.

Regulatory & Market Impact

  • Stock Trading Update: The company reaffirmed that the trading window for its securities remains closed for directors and designated employees in line with insider trading regulations.
  • Global Expansion: Bajaj Healthcare has an established presence in Europe, the USA, Australia, the Middle East, and South America, positioning itself as an international pharmaceutical player.

Conclusion

With this DCGI approval, Bajaj Healthcare Limited is set to expand its footprint in the Indian CNS pharmaceutical market while capitalizing on the growing demand for Pimavanserin globally. The move further aligns with the company's strategy to strengthen its pharmaceutical portfolio and market presence in India.
 
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