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Tech sheet – Apremilast

Tech sheet – Apremilast

Dr. Reddy's API Offerings*:

  • Dr. Reddy's is among the earliest generic API manufacturers globally for Apremilast API and filed the USDMF in September 2016 (Form-B) and June 2017 (Amorphous). Besides this, we have DMF filings in Canada and Brazil.
  • Offers the same form as the innovator drug, facilitating successful bioequivalence studies.

Manufacturing and Capacity:

We manufacture Apremilast at our cGMP API manufacturing facility in Vizag (CTO-SEZ), which is successfully inspected by global regulatory authorities, including the US FDA, and is EU GMP certified too. We have sufficient capacity to supply the commercial quantities in a short lead time.

To learn more, download the techsheet on Apremilast API HERE.

Should you have any specific queries? I would be happy to schedule a meeting at your earliest convenience.

*Note: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale.

 

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Email us: api@drreddys.com | +91 40 49002222

Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.