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Lake Chemicals readies to foray into US and EU markets with four CEP filings

PBR Staff Writer Published 27 June 2013

India-based Lake Chemicals has applied for four Certification of suitability of European Pharmacopoeia monograph (CEPs), in a bid to boost its entry into regulated markets such as EU and US.

Lake Chemicals managing director Manoj Palrecha was quoted by Pharmabiz as saying that the company already has the EU GMP certification and is currently engaged in talks with customers to enter the US market.

"The impact of the economic crisis had a detrimental impact and we have not grown as intended. Moreover, the US entry would also be fraught with strict surveillance on product quality and document submissions for Indian companies, post the Ranbaxy fiasco," Palrecha told the news agency.

"We are looking to capitalize the opportunities in the global market which accounts for 80 per cent of our revenues with sale of high quality products backed by required documentation and ensure time-line deliveries."

Furthermore, the company's facilities have been audited by Mexican regulatory agency, COFEPRIS, and it also has plans to file three CEPs in the coming months.

The company is also considering the Japanese market and has collaborated with companies such as Cipla, Sun Pharma to serve the Indian market.