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.
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