Caplin Point’s arm gets USFDA’s approval for Levetiracetam in Sodium Chloride Injection, infusion bags

17 Jan 2025 Evaluate

Caplin Point Laboratories’ Subsidiary--Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Levetiracetam in Sodium Chloride Injection, 500mg/100mL, 1000mg/100mL and 1500mg/100mL infusion bags (Large Volume Parenteral), a generic therapeutic equivalent version of the Reference Listed Drug (RLD), from HQ Speciality 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. 

Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy, in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy and in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. According to IQVIA (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 engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.


Caplin Point Lab Share Price

1963.05 -13.80 (-0.70%)
05-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1804.95
Dr. Reddys Lab 1275.05
Cipla 1520.55
Zydus Lifesciences 931.45
Lupin 2097.65
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×