Caplin Point Laboratories announced receiving final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05%. The approved drug is a generic therapeutic equivalent of Durezol, originally marketed by Sandoz Inc.

Key Highlights:

  • Product: Difluprednate Ophthalmic Emulsion, 0.05%
  • Purpose: A treatment for eye inflammation and pain post-surgery.
  • Subsidiary: The approval pertains to Caplin Steriles Limited, a wholly owned subsidiary of the company.

About Caplin Point Laboratories:

Caplin Point Laboratories is a fast-growing pharmaceutical company with a strong presence in emerging markets across Latin America and Africa. The company has robust manufacturing facilities and consistently delivers high cashflows, profitability, and revenue growth. Caplin Point has appeared on Forbes Asia’s “200 Best Under a Billion” list seven times in the past decade.

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TOPICS: Caplin Point