USFDA nod to Caplin Steriles Cisatracurium Besylate Injection

Published On 2023-06-12 11:09 GMT | Update On 2023-10-23 07:21 GMT

Chennai: Caplin Steriles Limited, a Subsidiary company 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) Cisatracurium Besylate Injection USP, 10 mg/5 mL (2 mg/mL) and 200 mg/20 mL (10 mg/mL) Single-dose Vials; and 20 mg/10 mL (2 mg/mL) Multiple-dose Vials (Preserved).

The product is a generic therapeutic equivalent version of (RLD), NIMBEX injection of AbbVie Inc.

Cisatracurium Besylate Injection USP is a nondepolarizing skeletal neuromuscular blocker, indicated as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgical procedures.

According to IQVIA (IMS Health), Cisatracurium Besylate Injection USP had US sales of approximately $35 million for the 12- month period ending December 2022.

C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented, “We’ve been consistent with our filings and also happy to receive approvals on time. We’re creating a healthy portfolio of products that we will launch not only in the US but in global markets as well. This approval will augment our growth plans for Caplin Steriles this year and the years going forward.”

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a niche sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP and ANVISA. Caplin Steriles Limited, has developed and filed 30 ANDAs in USA on its own and with partners, with 23 approvals so far, including this approval. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years.

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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

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USFDA nod to Caplin Steriles Cisatracurium Besylate Injection

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