vijaya.nuty@gvkbio.com
We can support with the supply of Midrodrine
Our manufacturing facility (GVK BIO) has approvals from worldwide regulatory authorities like below and these accreditations facilitate faster and easier approvals of DMFs/dossiers for our business partners.
a) In rare instance a joint audit was performed by auditors from USFDA, EDQM and Spanish MOH in 2013.
b) We are approved by PMDA (Pharmaceutical and Medical Devices Agency) Japan in 2012 and supplying commercially to customers in Japan including Pfizer Japan.
c) FDA Korea approved us in 2012, we have our presence for a decade in Korea market and we serve to almost 8-9 OEMs.
d) USFDA in 2015 & 2018