Image Source: WOWNEWS24X7
Indoco Remedies Ltd has received final approval from the USFDA for manufacturing Brivaracetam, an anti-epileptic drug used to treat partial-onset seizures in patients aged one month and older. Production will take place at its Verna, Goa facility, strengthening Indoco’s global pharmaceutical footprint and expanding its neurology-focused product portfolio.
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Key Highlights:
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Regulatory Milestone: Indoco Remedies Ltd has received final Abbreviated New Drug Application (ANDA) approval from the USFDA for Brivaracetam tablets.
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Therapeutic Use: Brivaracetam is prescribed for partial-onset seizures in patients aged one month and older, making it a critical treatment in epilepsy management.
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Manufacturing Hub: Production will be carried out at Indoco’s state-of-the-art Verna facility in Goa, which is USFDA-compliant and geared for global supply.
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Market Impact: The approval strengthens Indoco’s neurology portfolio and enhances its presence in the US generics market, one of the largest pharmaceutical markets worldwide.
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Strategic Growth: Analysts highlight that this approval aligns with Indoco’s strategy of expanding exports and diversifying its therapeutic offerings.
Contextual Insights:
Indoco Remedies, headquartered in Mumbai, has steadily built a reputation in generics and branded formulations. The USFDA approval for Brivaracetam underscores its ability to meet stringent regulatory standards while addressing critical healthcare needs. With epilepsy affecting millions globally, the drug’s approval positions Indoco to contribute meaningfully to neurological care while boosting revenues from international markets.
Sources: BSE Announcements, Economic Times Pharma, Indoco Remedies Official Filing
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