¿WHAT DOES GENERIC PRODUCTS WITH CERTIFIED QUALITY MEAN?

¿HOW MANY ARGENTINEAN PHARMACEUTICAL LABORATORIES ARE ABLE TO PROVIDE PRODUCTS WITH CERTIFIED QUALITY?

¿WHAT PHARMACEUTICAL LABORATORY CARRYING OUT PHARMACOSURVEILLANCE UNDER ICH OR FDA REGULATIONS DO YOU KNOW?

¿HOW MANY ARGENTINEAN PHARMACEUTICAL LABORATORIES CARRY OUR AN EXHAUSTIVE CONTROL OF THEIR RAW MATERIAL SUPPLIERS?

Laboratorio Dosa S.A. is a laboratory authorized to manufacture pharmaceutical products by official resolution Nª 223/96 issued by the Ministry of Health through the INAME Office in 1996. The decree authorises the manufacture of all our products in outer pharmaceutical plants, which are experts in the manufacture of medicinal specialities.

The above mentioned official resolution places the responsibility for the product quality to the laboratory propietary of the corresponding certificate. Because of this, Laboratorio DOSA S.A. has achieved a state-of-the-art technology as far as Laboratory instruments is concerned and has optimized the use of it training their people continuously.

Outer pharmaceutical plants are qualified accordingly and are inspected periodically by both national authorities and trained professionals from our own Laboratory. This complies with official resolution 853 outlines, now in force in Argentine Republic.

Nowadays in our country, the Law for Generic Products is in force. According to this Law, the quality of both ingredients and materials and manufacture methods make the difference between generic products from different laboratories.

Because of this, Laboratorio DOSA S.A. carries out an exhaustive control or active suppliers demanding them GMP certification. Beside, it uses all the available technology in order to verify it.

Further to the controls carried out at the Quality Assurance Area of our Laboratory, samples from our products are drawn at random monthly every month and the obtained results are validated in our laboratory before institutions of recognised academic prestige such as the Faculty of Pharmacy and Biochemistry (University of Buenos Aires), the University of Quilmes, National Institute of Industrial Technology, National Commission of Atomic Energy and National Counsel of Scientific and Technical Investigation.

Along with Onclology services from the highest clinical level, a Pharmacosurveillance program was developed for our injection products. This was achieved following ANMAT, FDA and ICH outlines.

The quality of Laboratorio DOSA S.A. products is certified before the manufacture has started since all our quality systems are validated according to internationals rules (FDA, ICH)*.

THIS IS WHY OUR PRODUCTS HAVE CERTIFIED QUALITY

*FDA: Food and Drug Administration.

*ICH: International Conference on Harmonisation of Technical

Requeriments for registration of Pharmaceuticals for Human use.

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