Bajaj Healthcare secures DCGI approval to manufacture Pimavanserin in India

Bajaj Healthcare Limited has received approval from the Drug Controller General of India (DCGI) to manufacture both the Active Pharmaceutical Ingredient (API) and Drug Formulation of Pimavanserin, a 34 mg capsule used to treat hallucinations and delusions associated with Parkinson’s disease psychosis.

Pimavanserin, marketed globally as NUPLAZID®, has gained significant traction in the US antipsychotic segment. Acadia Pharmaceuticals, which markets NUPLAZID®, recently projected that the drug, along with its other brand DAYBUE, is expected to generate over $1 billion in net sales in 2025.

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Bajaj Healthcare has extended its offer to manufacture Pimavanserin for several leading Indian pharmaceutical companies, ensuring widespread availability in the domestic market.

Speaking on the development, Anil Jain, Managing Director of Bajaj Healthcare, emphasized the significance of this approval, stating, “This marks a major milestone for Bajaj Healthcare. The growing success of NUPLAZID® in the US highlights 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 strengthens our presence in the central nervous system (CNS) segment and underscores our dedication to advancing healthcare solutions in India.”

Bajaj Healthcare, known for its strong manufacturing capabilities, aims to ensure that both the API and final product meet international quality standards. The company is leveraging its domestic presence and expertise to maximize the product’s success in India.

With this approval, Bajaj Healthcare aims to tap into the growing demand for advanced antipsychotic treatments in India. The move could also strengthen its position in the CNS segment and drive further growth in the Indian pharmaceutical sector.

This development comes at a time when India’s pharmaceutical industry is expanding its footprint in global markets, and Bajaj Healthcare’s approval for Pimavanserin production aligns with the company’s strategy to offer high-quality, innovative healthcare solutions.