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.

It functions as the primary active substance in finished dosage forms targeting neuropathic pain, epilepsy, and generalized anxiety disorder. The dominant commercial application is as the API in oral solid dosage forms.

Capsules and tablets are produced by generic and branded pharmaceutical manufacturers globally. Contract manufacturers and formulators source the material to produce finished drug products for regulated markets.

This requires full documentation packages including DMFs and CEPs. Secondary demand comes from pharmaceutical synthesis operations using the product as a 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. The substance is supplied as a white crystalline powder in various quantities.

Supply ranges from laboratory scale to multi-tonne commercial batches. The primary market grade is 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. These standards ensure the highest level of safety and efficacy for global distribution.

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