Regulatory Focus™ > News Articles > India's List of API Manufacturers Confirmed for Export to EU

India's List of API Manufacturers Confirmed for Export to EU

Posted 17 June 2013 | By Louise Zornoza

India's Central Drugs Standard Control Organization (CDSCO) has posted a List of Written Confirmations Granted that sets forth 57 active pharmaceutical ingredient (API) manufacturing sites in India that have been confirmed by the CDSCO as complying with the good manufacturing practice (GMP) requirements mandated by the EU for API imports as of 2 July 2013.

Major API producers such as Ranbaxy, Teva, and Mylan have several sites listed, which ensures that their exports will be permitted to enter the EU as of 2 July. India is a major exporter of API's and the List may be seen as welcome in Europe, given that the Heads of Medicines Agencies (HMA) - the heads of member state national regulatory agencies - sent a letter to the European Commission expressing concern that the Falsified Medicines Directive, which mandates the new rules governing API imports, might lead to a shortage of drugs in Europe.


CDSCO: API Export List

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Tags: API

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