Fulfilling the standards established for the Best Practice Manufacture Manual, Medquímica guarantees that the medicines put on the market possess assured quality and trustworthiness.
Moreover, through the performance of the Guarantee and Quality Control areas, diverse controls are carried through and a validation team proves the efficiency of the productive processes through applied studies later approved. Our Quality Control lab has been investing in the acquisition of new equipment, besides relying on a highly specialized technical team.
Currently, through the Development and Analytical Validation lab, we carry out the validation and the development of analytical methodology, participating even on the validation analysis of the productive process and the stability study of medicines.
By valuing the human element and investing its intellectual capital, Medquímica assures the quality of its product, in order to offer safety to its customers.
Medquímica possesses the Best Practice Manufacture Certificate for all its lines of production, proving that it fulfills the requirements integrally, as quality guarantee and control, sanitization and hygiene, validation, claims, collects, contracts, auto inspection, staff, installations, equipment, materials and documentation.
Two products are pharmaceutical equivalents if they contain the same amount of the same active substance, in the same pharmaceutical form, if they have identical or comparable patterns, and if they are indicated for administration through the same path.
It consists of the pharmaceutical equivalence demonstration between products presented under the same pharmaceutical form, containing identical qualitative and quantitative composition of active principle(s), and comparable bioavailability, when studied under one same experimental design.
Medquímica rigorously follows the current law on the accomplishment of tests in its medicines.
It is a similar medicine to a reference or innovative product, and that it is equivalent to the medicine registered in the responsible federal agency for the sanitary monitoring, being able to differ in characteristics regarding the size and the form of the product, stated period of validity, packing, labeling, excipients and vehicles, having to be identified by corporate name or mark.
It is a similar medicine to a reference or innovator product that intends to be interchangeable with it, generally produced after expiration or resignation of the patent protection or other rights of exclusiveness, proven its effectiveness, safety and quality.