Genus is an industry-leader in obtaining FDA approvals for previously-marketed unapproved drugs. Genus serves the public’s interest by taking previously-unapproved drugs, and bringing them through the drug approval process. This includes demonstrating that its manufacturing process can reliably produce products of expected identity, strength, quality, and purity. It also proves that the products are safe, and effective for intended use. The FDA has serious concerns that drugs marketed without the required review and approval may not meet modern standards for safety, effectiveness, quality, and labeling.
Genus’ facility resources include:
Genus Lifesciences manufactures and/or distributes several high quality products, all approved by FDA, under NDA, ANDA of supplemental NDAs. These products are distributed to retail chains, hospitals, mail-order companies, and other dispensing organizations through various wholesalers and distributors throughout the United States.
GMPS AND QUALITY SYSTEMS
Good Manufacturing Practices (GMPs) represent the code of quality that Genus Lifesciences employs in all aspects of its operations. It includes all aspects of pharmaceutical operations, including the production facility, analytical laboratory, employee training and other critical elements. Genus uses an active systems approach to ensure that its products meet and exceed high quality standards.