Andromedica production facilities are WHO certified. GMP standards vary from country to country. The United Nations WHO provides stringent requirements for certification of plants to the global standards of the WHO. This certification is known at WHO-GMP and is a mark of quality similar to the USFDA inspection standards.
Andromedica uses only the highest quality raw material manufactured to United States Pharmacopoeia (USP) or British Pharmacopoeia (BP) standards. From procurement of raw materials to packaging of finished product, our Quality Control (QC) team oversees every step of the manufacturing process.
All products are manufactured according to Good Manufacturing Practices (GMP) facility to ensure optimal quality. Our compliance with ISO 9001 regulations ensures that all aspects of our operations adhere to the highest quality standards.
All products are also analyzed by an independent third-party laboratory for verification of both potency and purity as per GMP and the pharmacopoeia standards.
Related focus includes facilities specializing in: • BE Studies & eCTD/CIS Dossier Development • Analytical Laboratories with Biological Support • Synthetic Organic / Custom API Development • Medical Device Manufacturing • Custom Recombinant Work
Swissmed offers in-licensing development of generic pharmaceuticals in our
R&D Center as well as outsourcing of full size commercial batch production.
In addition our regulatory affairs team is able to compile technical data as
per country specific dossiers and may assist in carrying out bioequivalence
studies through relevant clinical research organizations as per required
guidelines. Further, we have the capability of manufacturing final dosage
forms in country specific GMP approved facilities.