Caplin Steriles Limited (Caplin), a subsidiary company of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ephedrine Sulfate injection USP, 50 mg/mL Single Dose vial, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) AKOVAZ, from Exela Pharma Sciences LLC.
As per the company, “Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension occurring in the setting of anaesthesia. According to IQVIATM (IMS Health), Ephedrine Sulfate injection USP 50 mg/mL had US sales of approximately $36 million for the 12-month period ending May 2024.”
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, is a rapidly expanding sterile product manufacturer approved by many regulatory agencies including the US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited has developed and filed 42 ANDAs in the United States, both alone and with partners, with 29 approvals so far. The company is currently developing a portfolio of approximately 40 injectable and ophthalmic products, both simple and complex, which it plans to file over the next 4 years.
