The US Food and Drug Administration (FDA) has written to Sandoz after identifying significant violations of current good manufacturing practice (cGMP) at two of the company’s manufacturing sites in western India, Turbhe and Kalwa. Turbhe is an Active Pharmaceutical Ingredient and Finished Dosage Manufacturing Site, Kalwha is a Finished Dosage Manufacturing Site.
- INICIO
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Genéricos
Novedades
- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Investigación
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
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Biosimilares
Novedades
- China approves first denosumab copy biological Maiweijian
- EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost
- First denosumab biosimilars approved in Canada and the US
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
Investigación
- Topline results for Polpharma Biologics’ vedolizumab biosimilar candidate
- Comparing biosimilar adoption: Medicare Advantage versus traditional Medicare
- Cuestionando la necesidad de evaluaciones de sensibilidad étnica para anticuerpos monoclonales biosimilares
- ANVISA's role in biosimilar medicine regulation and innovation promotion
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