DCGI nod to Bajaj Healthcare for manufacturing Parkinson's disease psychosis drug Pimavanserin in India

Mumbai: Bajaj Healthcare Limited has announced that it has received approval from the Drug Controller General of India (DCGI) to manufacture both the API and Drug Formulation of Pimavanserin, a 34 mg capsule.

Pimavanserin is an atypical antipsychotic used for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Pimavanserin, marketed globally as NUPLAZID, has become a preferred treatment in the US antipsychotic segment. In a recent update, Acadia Pharmaceuticals announced that NUPLAZID, along with its other brand DAYBUE, is projected to generate more than $1 billion in net sales in 2025. The company has also extended offer for manufacturing of Pimavanserin to several leading Indian pharmaceutical companies, ensuring the product’s availability in the domestic market.

Speaking at the occasion Anil Jain, Managing Director, Bajaj Healthcare Limited, said, “The approval marks a major milestone for Bajaj Healthcare. The growing success of NUPLAZID in the US underscores the global demand for this innovative therapy, and 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 central nervous system (CNS) segment and highlights our dedication to advancing healthcare solutions in India. Bajaj Healthcare, with its strong manufacturing expertise, will ensure both the API and final product meet the international quality standards. Leveraging our strong domestic presence and expertise, we aim to maximize this product’s success and deliver meaningful value to the Indian market.”

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