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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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本目錄中的任何信息(包括對任何產品或服務的任何引用)均不構成銷售要約,或被解釋為代表銷售要約。受有效專利保護的產品不提供或供應用於商業用途。但是,只要存在此類監管豁免,就可以出於監管提交的目的提供此類產品的研究數量。買方應對各自市場的專利方案進行獨立評估,並承擔所有與專利相關的責任。在印度受有效專利保護的產品不可用於商業用途,但可用於第 107A 節。

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