Caplin Steriles receives USFDA approval for two drugs

21 Mar 2023 , 02:33 AM

Lupin announced that its alliance partner has obtained two approvals from the US Food and Drug Administration (USFDA).

The USFDA has granted the final approval to Caplin Steriles, a partner of Lupin, to market its generic version of Zemuron Bromide Injection, 50 mg/5 ml and 100 mg/10 m,l produced by Organon USA Inc. 

Caplin Steriles obtained this approval through its abbreviated new drug application (ANDA) for Rocuronium Bromide Injection, 10mg/ml, which will be available in 5 ml and 10 ml multi-dose vials.

In the United States, Rocuronium Bromide Injection recorded an annual sale of around $53 million.

Furthermore, Lupin’s partner Caplin Steriles has also received the final approval from the FDA for its Thiamine Hydrochloride Injection USP, 200 mg/2 ml (100 mg/ml) in multiple-dose vials. 

This approval allows Caplin Steriles to introduce a therapeutically equivalent version of Fresenius Kabi USA LLC’s Thiamine Hydrochloride Injection USP, 200 mg/2 ml (100mg/ml).

In the United States, sales of Thiamine Hydrochloride Injection USP amounted to roughly $36 million on an annual basis.

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