Caplin Steriles Gets USFDA Approval For Ofloxacin Otic Solution

Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ofloxacin Otic Solution 0.3 per cent, a generic therapeutic equivalent version of (RLD), FLOXIN Otic Solution of Daiichi Pharmaceuticals Inc., the company on Monday announced through an exchange filing.

Ofloxacin Otic Solution 0.3 per cent is used as anti-infective (antibacterial) for otic (ear) use. According to IQVIATM (IMS Health), Ofloxacin Otic Solution 0.3 per cent had US sales of approximately US dollar 36 million for the 12-month period ending June 2023.

Caplin Steriles Limited shares

The shares of Caplin Steriles Limited on Monday at 2:19 pm IST were at Rs 1,392, down by 0.55 per cent.

About Caplin Steriles Limited

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 37 ANDAs in USA on its own and with partners, with 25 approvals so far