Caplin Point Lab arm receives USFDA nod for seizures treatment injection

Caplin Point Laboratories has announced that its subsidiary, Caplin Steriles, has received final nod from United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Levetiracetam in sodium chloride injection.

Levetiracetam in sodium chloride injection is an antiepileptic drug indicated for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy, myoclonic seizures in adults with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy."

The said drug is a generic therapeutic equivalent of the Reference Listed Drug (RLD) from HQ Specialty Pharma Corp.

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles, with a further 6 products under review with FDA for RTU Bags segment.

According to IQVIATM (IMS Health), Levetiracetam in Sodium Chloride Injection had US sales of approximately $19 million for the 12-month period ending November 2024.

Caplin Point Laboratories is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company has manufacturing facilities that cater to a complete range of finished dosage forms.

The companys consolidated net profit grew 14.04% to Rs 130.80 crore on 17.81% increase in revenue from operations to Rs 483.10 crore in Q2 FY25 over Q2 FY24.

The scrip slipped 1.27% to Rs 2,241 on the BSE.

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