Caplin Steriles gets USFDA nod for Ofloxacin Otic Solution

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) Ofloxacin Otic Solution 0.3%.

It is a generic therapeutic equivalent version of (RLD), FLOXIN Otic Solution of Daiichi Pharmaceuticals Inc.

Ofloxacin Otic Solution 0.3% is used as anti-infective (antibacterial) for otic (ear) use.

According to IQVIA (IMS Health), Ofloxacin Otic Solution 0.3% had US sales of approximately $36 million for the 12-month period ending June 2023.

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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. 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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