Pregabalin

Pregabalin (CAS 148553-50-8), also referenced in development literature as PD 144723 and S-(+)-3-isobutylgaba, is a synthetic gamma-aminobutyric acid analogue manufactured as an active pharmaceutical ingredient.

Where is Pregabalin used?

• Neuropathic pain, epilepsy and generalized anxiety disorder: primary active substance in finished dosage forms
• Oral solid dosage forms: dominant commercial application as the API
• Capsules and tablets produced by generic and branded manufacturers globally
• Contract manufacturers and formulators produce finished drug products for regulated markets, requiring full documentation packages including DMFs and CEPs
• Pharmaceutical synthesis: reference standard or process intermediate during analytical method development
• Quality control, academic and clinical research procurement represents a smaller but consistent demand channel for high-purity material.

Commercial specifications

• Supply ranges from laboratory scale to multi-tonne commercial batches
• Pharmaceutical-grade material manufactured under ICH Q7 GMP guidelines, with compliance to USP, Ph. Eur. and BP monographs
• Certificates of Analysis, impurity profiles and regulatory support documentation are standard expectations for pharmaceutical supply chain qualification