Quality Medigen Pharmaceuticals

FDA Licenses

Quality Medigen Pharmaceuticals is proud to hold the following essential licenses from the Food and Drug Administration (FDA), demonstrating our full compliance with drug distribution regulations:

• Form 20B: Wholesale Drug License

  This license permits us to conduct the business of wholesale of drugs other than those specified in Schedule C, C(1) and X. It ensures that our premises, storage, and distribution practices meet the stringent requirements for general drug wholesale.

• Form 21B: Wholesale Drug License for Schedule C & C(1) Drugs

  This license specifically authorizes us to wholesale drugs specified in Schedule C and C(1) (biological and other special products) to the Drugs and Cosmetics Rules, 1945. This includes critical items like vaccines, sera, and other biological preparations, which often require specialized handling and storage (e.g., cold chain management).

These licenses are regularly renewed and our operations are subject to periodic inspections by regulatory authorities, ensuring continuous adherence to the highest standards.

Our Quality Assurance

• Good Distribution Practices (GDP): We implement rigorous GDP guidelines to ensure that the quality and integrity of medicines are maintained throughout the supply chain, from manufacturer to end-user.
• Temperature Controlled Storage: Our warehouses are equipped with state-of-the-art temperature monitoring systems to ensure optimal storage conditions for all products, especially those requiring cold chain management.
• Traceability & Authenticity: We maintain comprehensive records for complete traceability of every product, ensuring authenticity and preventing counterfeit drugs from entering the supply chain.
• Regular Audits & Training: Our facilities and processes undergo regular internal and external audits. Our staff receives continuous training on regulatory updates and best practices.
• Risk Management: We have robust risk assessment and management protocols in place to identify and mitigate potential risks throughout the distribution process.