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White Paper

Tech Sheet on Linagliptin

Tech Sheet on Linagliptin

Linagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4), an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis.

We are among the earliest generic API manufacturers globally to file the USDMF for Linagliptin API. The DMF for Korea is also filled. We offer country-specific regulatory filings for global market expansion, so we are diversifying our filing to all the major regulated markets.

Our API offerings:

  • We offer a mixture of crystalline Form A and Form B - a prior art form
  • A process which is improved and disclosed in the product patent and designed around the innovator's process IP.
  • Quality by design (QbD) based API development for a consistent quality profile

Our process has been designed to address customized PSD requirements through size reduction and crystallization techniques to consistently meet the most desired PSDs at a commercial scale.

To know more about our API offerings, please read the Tech sheet on Linagliptin by filling the contact form below.

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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.

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