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ANVISA Certification of GMP Pharmaceutical Ingredients for 61 of Dr Reddy’s APIs

We are glad to announce the publication in the OFFICIAL DIARY OF THE UNION of Brazil the granting to Dr. Reddy’s Laboratories Limited, the Certification of Good Practices of Manufacturing of Pharmaceutical Ingredients 61 of Dr Reddy’s APIs.

This ANVISA GMP Certifications covers all our API’s commercialized and under development in the Brazilian market from six of our manufacturing plants.

Please click here to view the list of all certified API’s and manufacturing plant site.

This achievement was only possible through the combined hard work of our Expert RA & QA Teams based in Brazil and India, specially focused in complying with the latest regulations issued by ANVISA.

Summing to our achievement in our GMP numbers, there is also the number of 31 DIFAs already prepared in 2020, complying with CADIFA regulation RDC 359/20, plus the number 33 coming in this year of 2021.

Our Latam RA Team expertise lies in the fact that all its members are composed from ex-employees of the Pharmaceutical Industry, this gives us a high understanding of what is needed from our clients and from ANVISA.

Our Latam RA/QA support is unmatched in the market as we are able to offer solutions ranging from Plant Audit Support, Particle Size troubleshooting, Patent landscape, Expertise in Nitrosamines, Azido Impurities and other M7 concerned impurities.

Please reach out to us on api@drreddys.com for any queries or support required on your API requirements.

 

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Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.

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