Mumbai, Jan 17 : Unichem Laboratories has received a series of approvals from international drug regulatory authorities. The approvals received by Unichem are from Therapeutic Goods Administration (TGA), Australia, Medicine Control Agency (MCA), UK and Medicine Control Council (MCC), South Africa.These approvals will pave the way for Unichem Laboratories to enter the highly regulated markets in the European Union, Australia and South Africa, a company press release added.The TGA, Australia has granted approval for Unichem Laboratories' solid dosage forms manufacturing facility at Goa. This manufacturing facility also has the prestigious MCA, UK approval, which is products specific along with the approval of MCC, South Africa.
MCC has also granted approval for Unichem's beta-lactum antibiotic manufacturing unit at Baddi in Himachal Pradesh.
Unichem Laboratories plans to enter the highly regulated large volumes markets with high value-added products as part of its international business strategy.
According to Unichem chairman and managing director Dr PA Mody, "We have already started exporting to the UK market under a contract manufacturing agreement. The company is in a process of formulating a long-term business and strategy plan for these markets."
He added that the regulatory/registration process in these countries could take upto three years.
Copyright © 2001 Indian Express Newspapers (Bombay) Ltd.
