US FDA has given approval to Medley at a time when mostly pharma majors are getting rejection hugely. A big congratulation not only to Medley but to the Indian Pharma Industry.
US FDA audit conducted at Medley pharmaceuticals from 15th February to 19th February, 2016.There were no major observations (483s) for this 5 days long extensive audit.This is a great achievement by Medley in contrast to the current scenario of US FDA audits of Indian Pharma companies.
Sun Pharma joined the long list of companies last year against whom warning letters have been issued year, while in November 2015 the USFDA raised concerns on Dr Reddy’s manufacturing practices at three of its plants.US FDA issued warning letter to seven companies in last year 2015 and name of the companies are Cadila, Dr.Reddy,Unimark, Pan Drugs,Sipra Labs, Mehendra chemicals and Micro Labs.
In this environment, Indian companies need to improve learning processes systematically and vigorously. Dr.Arif Farooqui, Vice President Medley, says, we should be more proactive in regulation implemention so that we can face the audit easily. He says, What US and Europe faced regulatory vigilance 10 years back, India is facing now. There is no issue with product quality with domestic generic drugs, but what needs to be followed strictly is documentation and processing at the manufacturing facilities.”
Medley is a global pharmaceutical company operating since 1969 from Mumbai, India. Since launch, the company consolidated its position with a strong manufacturing and marketing infrastructure. Medley employs more than 2500 people , of which approximately 1750 are part of the sales force , around 600 associates in corporate & manufacturing across India & 100 in International Business. Medley ranks amongst the top 40 pharmaceutical companies in India as per ORG IMS.
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