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Anti-Epileptic
Pregabalin API Manufacturer India
CAS 148553-50-8 · Manufactured by Reine Lifescience, Ankleshwar, Gujarat, India
IP, BP, EP, USP✓ DMF FiledAnti-Epileptic
Pregabalin (CAS 148553-50-8) is a anti-epileptic active pharmaceutical ingredient manufactured by Reine Lifescience in Ankleshwar, Gujarat, India, supplied in IP, BP, EP and USP grades, with a DMF on file.
Overview
An anticonvulsant and neuropathic pain agent for neuropathic pain (diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury, fibromyalgia) and adjunctive therapy in partial-onset seizures. Binds selectively to alpha-2-delta subunit of voltage-gated calcium channels. CEP Under Approval (CEP-2025-014).
Specifications
CAS Number148553-50-8
Therapeutic CategoryAnti-Epileptic
Pharmacopoeia GradeIP, BP, EP, USP
DMF StatusFiled
Manufactured ByReine Lifescience, India
Regulatory & Compliance
WHO-GMP Certified Manufacturing Facility
World Health Org. Good Manufacturing Practice — Certified Facility
EDQM CEP Certified
Certificate of Suitability (EDQM) — CEP-2025-014 Under Approval
ANVISA Brazil — Approved
Brazilian Health Regulatory AgencyFrequently Asked Questions
What is the CAS number of Pregabalin?
The CAS number of Pregabalin is 148553-50-8.
Which pharmacopoeia grades of Pregabalin does Reine Lifescience supply?
Reine Lifescience supplies Pregabalin in IP, BP, EP and USP grades.
Does Reine Lifescience have a DMF for Pregabalin?
Yes, Reine Lifescience has filed a Drug Master File (DMF) for Pregabalin.
What regulatory approvals does Pregabalin have?
Pregabalin is backed by: WHO-GMP Certified Manufacturing Facility, EDQM CEP Certified, ANVISA Brazil — Approved.
How do I request a quote for Pregabalin?
Fill the enquiry form on this page, or contact Reine Lifescience with the product name, grade and required quantity.
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About Reine Lifescience
Devoted to Life
Reine Lifescience is a WHO-GMP and EDQM CEP accredited active pharmaceutical ingredient manufacturer based in Ankleshwar, Gujarat, India, manufacturing Pregabalin and a portfolio of APIs for pharmaceutical partners worldwide.
Approvals for Pregabalin
WHO-GMP Certified Manufacturing FacilityEDQM CEP CertifiedANVISA Brazil — ApprovedProduct Enquiry
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