INTERNATIONAL MARKETS SUPPORT
At Mallinckrodt Pharmaceuticals, we have a deep understanding of the changing regulatory environments in international markets, and we are here to help ensure you and your products meet the guidelines of more than 60 countries on six continents. As your trusted partner, we offer the following services to help you navigate the evolving environment of the global API trade:
- We are committed to meeting your technical documentation requests to help bring your products to market, including BSE/TSE documentation, product data specifications, Material Safety Data Sheets, GMP documentation and copies of United States (US) Food and Drug Administration inspections’ documentation.
- Our 40 years of global sales experience can help to shorten the approval process by the European Directorate for the Quality of Medicines. We also promptly provide customized mixed master files for any of our API-and-excipient-mixed products. In 2011, we received Certificates of Suitability of Monographs of the European Pharmacopoeia for our controlled substances products.
Successful “Dosage” API Good Manufacturing Practices (GMP) Site Inspection
- Our Greenville, Illinois, site, producer of Compap™ L, received international approval from the Medicines and Healthcare products Regulatory Agency of England, which awarded the plant a GMP certificate. Now our Compap L products meet the more stringent European requirements for dosage product applications.
- We’re invested in the future of the international API market, and have made significant capital improvements to our plants and facilities to ensure our API products meet GMP standards now and in the future.
Trade Regulation Compliance
- We assist you in meeting the highest international trade standards through value-added services like shipping on heat-treated pallets, meeting International Standards for Phytosanitary Measures No. 15 (ISPM 15), to prevent contamination. We also follow classification, labeling and packaging regulations by printing our labels in multiple languages to ensure you receive timely customs approvals.
- We protect our products and your customers from contamination through certification of the security of our supply chain by the Customs Trade Partnership Against Terrorism and approval of our controlled substances shipping facilities as Certified Screening Facilities by the US Transportation Security Administration.
With dedicated regulatory affairs and logistics assistance, at Mallinckrodt, we are committed to providing you value-added customer service, helping to ensure your products safely get into the hands of the patients who need them all over the world. We look forward to servicing your business as your supplier of choice.