Sunday, 29 January 2017 21:00

Prati-Donaduzzi clarification note

PRATI - DONADUZZI informs that it has held the registration of the losartan product since 2009, meeting all strict ANVISA requirements, as well as performing quality controls on all manufactured batches. It uses, in its production processes, equipment and systems with the highest technology available in the world market, including certification of Good Manufacturing Practices, issued by ANVISA.
Analyzing the Reports of Pharmaceutical Equivalence and Dissolution Profile performed by the laboratory contracted by Fantástico program from TV Globo, it is verified that lot 16B41K of the losartan 50 mg meets all quality specifications, as follows:
As for the analysis of active substance content, losartan, from PRATI DONADUZZI, had a result of 99.25%, that is, higher than the reference drug (Cozaar), according to the table below:

 Analysis

 Losartan
PRATI DONADUZZI

 Cozaar
MSD

Content

99.25%

98.21%

In relation to dissolution profile analysis, the drug losartan, from PRATI DONADUZZI, showed a faster action when compared to the reference drug (Cozaar), according to the table below:

 

Analysis

 Losartan
PRATI DONADUZZI

 Cozaar
MSD

Dissolution 10 min

72.71%

59.43%

Dissolution 15 min

86.78%

76.11%

Dissolution 20 min

98.86%

87.91%

Dissolution 30 min

102.13%

102.76%

It is noteworthy that the fact that the dissolution was faster than the reference drug does not cause any harm or loss to the patient and to the treatment. Nevertheless, PRATI reports that it has carried out a new analysis, according to the USP and British Pharmacopoeia method, in lot 16B41K, manufactured on 02/2016, internally and in two other external laboratories, duly authorized by Anvisa, where all results were fully satisfactory.
Finally, for any further clarifications, the company is available through its Customer Service Center, by phone 0800-709-9333, from Monday to Friday, from 7:10 am to 7:10 pm, by e-mail cac @ pratidonaduzzi.com or by www.pratidonaduzzi.com.br.

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