Caplin Steriles gets USFDA nod for Labetalol Hydrochloride Injection

Written by Ruchika Sharma Published On 2021-09-08T14:05:15+05:30 | Updated On 13 Oct 2023 5:22 PM IST

Caplin Steriles gets USFDA nod for Labetalol Hydrochloride Injection

Labetalol Hydrochloride Injection USP is indicated for control of blood pressure in severe hypertension.

Chennai: Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has been granted final approval by the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Labetalol Hydrochloride Injection USP, 100 mg/20 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL) Multiple-dose Vials.

The product is a generic therapeutic equivalent version of (RLD), TRANDATE Injection, of Sebela Ireland Limited.

Labetalol Hydrochloride Injection USP is indicated for control of blood pressure in severe hypertension.

According to IQVIA (IMS Health), Labetalol hydrochloride Injection had US sales data of approximately $6 million for the 12-month period ending June 2021.

Caplin Steriles Ltd, a Subsidiary of Caplin Point Laboratories Limited, is a niche sterile product manufacturing company that is approved by USFDA, EU-GMP, ANVISA-Brazil and several other regulatory agencies. Caplin Steriles Limited, has developed and filed 20 ANDAs in USA on its own and with partners, with 17 approvals so far. Out of the 17 approvals, 12 belong to Caplin Steriles. The Company is also working on a portfolio of 45 simple and complex Injectable and Ophthalmic products to be filed over the next 4 years.

Read also: Caplin Steriles secures USFDA nod for Neostigmine Methylsulfate Injection

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751