Isotretinoin API Product Category: Active Pharmaceutical Ingredient (API) CAS Number: 4759-48-2 Molecular Formula: C20H28O2 Molecular Weight: 300.44 g/mol Grade: Pharmaceutical Grade (USP / BP / Ph.Eur / IP – as applicable) Product Overview Isotretinoin is a retinoid derivative of Vitamin A widely used in the formulation of oral solid dosage forms for dermatological indications. It is recognized for its efficacy in the management of severe acne and related skin conditions. Isotretinoin API is utilized by pharmaceutical manufacturers serving regulated and semi-regulated markets under strict quality and regulatory controls. Applications Isotretinoin is indicated for: Severe nodular or cystic acne Acne resistant to conventional therapy Other approved dermatological indications as per regulatory authorities All applications must comply with approved prescribing information and national regulatory guidelines. Quality & Compliance Our Isotretinoin API is sourced from GMP-compliant manufacturing facilities with validated quality assurance systems. Each batch is supplied with: Certificate of Analysis (COA) Material Safety Data Sheet (MSDS / SDS) Batch traceability documentation Stability data (upon request) Pharmacopoeial compliance documentation DMF support (where available) Packaging & Supply Light-protected and moisture-controlled packaging Export-grade HDPE or fiber drums with double inner liners Customized labeling and complete export documentation Bulk supply for domestic and international markets Regulatory Notice Isotretinoin is a prescription pharmaceutical ingredient with strict regulatory controls in many jurisdictions. Buyers are responsible for ensuring compliance with applicable licensing requirements, regulatory approvals, and import regulations prior to procurement.