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Tech Sheet on Pregabalin API

Tech Sheet on Pregabalin API

Pregabalin's precise mechanism of action is not fully understood, but studies suggest that it binds to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. This binding modulates the release of excitatory neurotransmitters and prevents the trafficking of the alpha2-delta subunit. Although pregabalin is structurally related to GABA, it does not directly bind to GABA or benzodiazepine receptors.

Dr. Reddy's API Offering

  • Offers crystalline form-I i.e., Innovator form.
  • The control strategy for the API impurity profile has been designed through quality-by- design (QbD) based development.
  • Lactam impurity levels are not detected thus able to achieve USP/ EP compliance after milling - opening a possibility for a wide range of delivery systems like dispersible films, oral disintegrating tablets, etc.

We manufacture Pregabalin API at our cGMP API manufacturing facility, which was successfully inspected by international regulatory authorities - WHO GMP, KFDA, PMDA, ANVISA, and USFDA.

To know more about our API offerings, please read the Tech sheet on Pregabalin API 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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