An impurity detected above specification limits in an active ingredient manufactured by Mylan India
Teva Pharmaceuticals has voluntarily withdrawn all lots of Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active ingredient manufactured by Mylan India. The impurity is N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.
Mylan N V is a global generic and specialty pharmaceuticals company registered in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK and global headquarters in Canonsburg, Pennsylvania, US.
Mylan being one of the world’s leading generic and specialty pharmaceutical companies, have a strong manufacturing base with Active Pharmaceutical Ingredients, Oral Solid Dosage and Injectable units spread across the country. The company also has exceptional R&D facilities and fast growing commercial operations in India. Mylan India comprises of nearly per cent of Mylan’s total global workforce.
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