Lake Chemicals, the dedicated active pharmaceutical ingredient (API) major, has filed four Certification of suitability of European Pharmacopoeia monograph (CEPs) for its products. The company is expected to have another three CEPs from EDQM within the next few months. These efforts are to ensure that its foray into the regulated markets are further strengthened.

The company also received the EU GMP certification and will now make all efforts to export to the European Union. Another development at the company is that its facilities in the outskirts of Bengaluru underwent an audit by Mexican regulatory agency COFEPRIS which comes under the Ministry of Mexico.

For its US entry, it is in dialogue with customers there and has filed the Drug Master Files (DMFs), Manoj C Palrecha, managing director, Lake Chemicals told Pharmabiz.

The company’s foray into EU and US have not gained much momentum because the global slowdown. “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,” he added.

Lake is known for its APIs in the anti-psychiatry and ophthalmic space. It is a leading manufacturer of Benzodiazepine and is already approved source for global  pharma majors including the originators for a few of the products.

The growth for Lake Chemicals will be organic and there are no plans for acquisitions. “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. This would be the only way to gain and retain customer confidence,” he said.

Current game plan would be to wait and watch how the European Union unfolds to attract the Indian API players like Lake Chemicals, he said.

As part of its global foray, Lake will also look at Japan because it has emerged as a focus market for India following its switch from expensive patented drugs to cheaper generic versions. We explored Japan seven years ago and now will look for an entry, he said adding that the company is beginning to look at having discussions with trading partners.

Although therapy segments gaining ground are anti cancer, yet anti psychiatry and ophthalmology are indispensable in today’s disease landscape. Lake would look at increasing its markets with its specialized APIs in anti psychiatry and ophthalmology. While growth prospects in the regulated market are on an upswing, in the unregulated region could witness a de-growth. This is attributed to the United Nations directions on redefining import norms of anti-psychotic drugs based on per population requirement, he said.

Currently India has 3,000 API manufacturers but only 2,000 of the units cater to the needs of small-medium formulation majors which are sensitive to pricing and therefore cost competition could make it difficult to generate the adequate revenues, he observed.

In order to cater to the domestic market needs, Lake Chemicals has tied up with top Indian pharma companies spanning from Cipla to Sun Pharma.

Commenting on the new regulations for API industry, which is the Falsified Medicine Directive from the European Union, he said that from an industry perspective, there could be inordinate delays for issuing the written confirmation (WC) certificate, confirming compliance with GMP standards that are 'equivalent to the rules applied in the EU', like the WHO GMP, 'International Conference for Harmonization' Q7 (ICH Q7), etc. effective from July 2, 2013.

There are also serious issues spanning from workforce availability to talent crunch, besides handling of pollution control issues and delays in the regulatory clearances. Now despite these issues, Indian APIs are preferred by global majors.  In fact the country is now seen to be preferred over China and this would see the contract manufacture orders return. While this is a favourable phase for Indian API to garner much of the global orders, the industry expects support from the government with faster regulatory approvals, simplified norms for clearances and dedicated chemical zones to prevent problems of effluent discharge, said the Lake Chemicals chief.