US FDA Approves Carboprost Tromethamine Injection by Caplin Steriles

HEALTHCARE

According to Caplin Point Laboratories Ltd., its subsidiary, Caplin Steriles Ltd., has received final FDA approval for carboprost tromethamine injection, which is used to treat postpartum hemorrhage caused by uterine atony.

Postpartum hemorrhage, which results in excessive bleeding after delivery, is primarily caused by uterine atony.

Carboprost Tromethamine Injection USP, 250 mcg single-dose vials have received abbreviated new drug application (ANDA) approval from the US FDA. According to CC Paarthipan, Chairman of Caplin Point Laboratories, they are expecting two or three more approvals in the coming months as they look to expand their footprint in the United States. This is the generic therapeutic equivalent version (RLD) of Hemabate Injection from Pfizer Inc.

For the twelve months ending in September 2022, the drug was sold for approximately $55 million in the United States, according to IQVIA data. In the United States, Caplin Steriles has created and submitted 28 abbreviated new drug applications (ANDAs) alone and with partners. So far, the business has received 19 approvals.

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In addition, the pharmaceutical major is working on a portfolio of over forty injectable and ophthalmic products, both simple and complex, that it plans to file over the course of the next four years. Caplin Steriles is a niche manufacturer of sterile products that has received approval from a number of regulatory bodies, including EU-GMP and the USFDA.