In an effort to expand its reach in the regulated markets of US and Europe, the Ahmedabad-based Marck Biosciences Ltd, a noted manufacturer and marketer of sterile liquid parenterals, is likely to file for US Food and Drug Administration (FDA) approval for its facility at Kheda in the next six months.
The company, which at present carries out contract manufacturing for its clients in the regulated markets, is also planning to acquire a medium-sized company in US in the near future to better penetrate this regulated market. Also, the company keeps its doors wide open for possible tie-ups with companies in US and EU.
"Though we have bagged approvals from Brazil and Malaysia, so far we haven't made any attempt to get US FDA approval for our facility. But, this will happen in the near future. We are in talks with our customers in US and would initiate the steps to get US FDA approval in the next six months. Besides, we are also planning to acquire a mid cap company in US soon," said Bhavesh Patel, managing director, Marck Biosciences.
The company also doesn't rule out the possibilities for tie-ups with companies in either US or EU. Speaking to Pharmabiz, Bhavesh Patel disclosed that Marck Bioscience is in discussions with a couple of companies in these countries and there would be something conclusive by this November or December.
As of now, Marck Bioscience has presence in more than 65 countries in four continents. Though the company's manufacturing activities are limited to its two facilities in Ahmedabad, the company has a countable number of importers in countries like Africa, Latin America and South East Asia, to whom it provides promotional and sales back up services.
When it comes to regulated markets like US and EU, Marck Bioscience provides contract manufacturing services to a couple of companies that have registration in these regions. In certain cases, the company works together with its customers in US and EU right from development stage - development of formulations to stability to scale up to transfer of technology to supply agreement. Also, the company makes filings for its clients.
Besides this, the company also exports irrigation solutions, which is sterile in nature, to these markets and is expected to include its therapeutic products in the export list once it bags US FDA approval.
With the completion of expansion of its facility in the last year, Marck Bioscience's manufacturing capacity has increased 100 per cent and as a consequence its national sales are expected to increase three fold in the coming years.