Our cGMP-compliant formulation manufacturing facilities manufacture a vast range of injectables using aseptic filling or terminal sterilization, as applicable. We are capable of production flexibility and product lines switching, eliminating need to install additional production lines to meet altered product specifications and market mechanics of demand and supply. Our facilities have been inspected by the following regulatory bodies and received several product approvals:
UK’s MHRA (United Kingdom’s Medicines and Health products Regulatory Agency) MCC South Africa (Medicines Control Council) BGV Germany (Behörde für Gesundheit und Verbraucherschutz – Hamburg) US FDA (United States Food and Drug Administration) ANVISA Brazil (National Health Surveillance Agency) TGA Australia (Therapeutic Goods Administration) WHO (World Health Organization)
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Ad Detail: COMPLIANT FORMULATION MANUFACTURING FACILITIES (CGMP)
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