Bajaj Healthcare Gets Approval from DCGI to Manufacture Pimavanserin in India

Bajaj Healthcare Limited (BHL) has received approval from the Drug Controller General of India (DCGI) to manufacture Pimavanserin, including both its Active Pharmaceutical Ingredient (API) and drug formulation in the form of a 34 mg capsule.

The company has also extended manufacturing offers for Pimavanserin to several Indian pharmaceutical companies, ensuring that the drug is available in the domestic market.

What is Pimavanserin?

Pimavanserin is an atypical antipsychotic used to treat hallucinations and delusions in patients with Parkinson’s disease psychosis. It is marketed globally under the brand name Nuplazid and has gained recognition as a treatment option in the US antipsychotic drug market.

Presence and Global Sales

Acadia Pharmaceuticals, which sells Nuplazid, recently projected that combined net sales of Nuplazid and its other brand, Daybue, will exceed $1 billion in 2025. The drug has established itself in the US market as a preferred treatment in its category.

Background

Bajaj Healthcare was established in 1993 and manufactures APIs, intermediates, formulations, and nutraceuticals. It has operations in Europe, the US, Australia, the Middle East, and South America. The company has a market capitalization of over ₹2,100 crore.

Regulatory Disclosure

As per SEBI’s (Prohibition of Insider Trading) Regulations, 2015, the company’s trading window remains closed for directors and designated employees following its prior disclosure dated December 27, 2024.

The approval allows Bajaj Healthcare to produce Pimavanserin for the Indian market, making it available as a treatment option for Parkinson’s disease psychosis.

Market Reaction

Following the announcement, as of January 30, 12:49 PM, Bajaj Healthcare Ltd is trading at ₹637.30, down 2.90% (₹19.00) for the day, but has gained 66.38% over the past six months and 89.59% over the past year.

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