Merck Millipore says Indian lab can boost generics quality

Merck Millipore, the life sciences tools division of Merck KGaA, has launched a solid dose formulation lab in India, its first outside Europe.

At the site’s inauguration ceremony, the head of Merck Millipore India highlighted the need for a facility in the region, saying India is one of the largest exporters of pharmaceutical products to North America and the European region despite recent quality problems.

Between 2009 and 2013 exports from India registered an average growth of 24% – almost unaffected by the overall economic situation,” said Claus-Dieter Boedecker.

India also has the highest number of US FDA [Food and Drug Administration] approved facilities outside the US – 323 as of March 2013 – of which most have approvals from authorities in Europe, Canada and Australia.

The new lab will help Indian generics makers with both time-to-market and quality problems in their manufacturing processes, he said.

The quality standard achieved by Indian pharmaceutical companies […] has been overshadowed by the recent spate of quality concerns. These could adversely affect export performance going forward.

Additionally, speed is of essence in the field of generics. With the new facility, Merck intends to deliver on both these parameters.

API problems

The site, named a Process Solutions Formulation Lab, will provide services to pharmaceutical clients working on solid dose formulations. This will include application assistance for pre-formulation studies using advanced excipients from the Merck Millipore portfolio.

Merck Millipore India’s Head of Pharm Chemicals Solutions, Peter Salazar, detailed some of the problems pharmaceutical companies experience with formulation.

A large number of active drugs have problems of low solubility and low permeability. Incidentally, the majority of active ingredients under development have the same problems. These are, therefore, not only difficult to formulate, but in the absence of an appropriate technology, need to be used in high concentrations in order to be effective.

Enhanced product performance studies and comparison studies can be conducted at the new lab, he said, as well as hands-on training to clients in specific areas of application.

Merck Millipore’s Head of Sales in Asia for Process Solutions, said the lab will reduce costs and build in-house capabilities, citing the adage “time is money” as especially relevant to the generics industry. “Merck Millipore intends to sharpen its clients’ competitive edge by providing faster solutions to formulation design problems; thereby reducing costs,” said Benoit Gourdier.

The company said it located the lab in Nerul in Mumbai, India for its transport links to the major pharmaceutical manufacturing centres at Ahmedabad, Goa and Hyderabad.

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