Dishman Pharma plans to bring intermediates made in China facility to India

The co will make APIs here using the intermediates; signs license agreement with Janssen to supply API for MDR TB drug globally

Leading contract research and manufacturing services (CRAMS) player Dishman Pharmaceuticals and Chemicals Ltd, which is now targeting the life saving drugs market, is planning to bring intermediates from its China plant to India, convert them into active pharmaceutical ingredients (APIs) and sell both in the domestic as well as the international markets.

This would give the company a huge cost advantage, which when passed on to customers and can make Dishman competitive vis-a-vis the other API players. Speaking to the media here, Dishman's managing director Arpit Vyas said that the company was eyeing a $5-8 million revenue from its China facility this fiscal.

 

"We had posted a loss of around Rs 24-25 crore from the China facility in FY14, and during the last fiscal, we managed to break even at the facility. This year, we have already started generating profits, and are working to get an export GMP approval for the plant," Vyas said adding that the company was also working to get approvals to make APIs at the plant within the next 18 months. Dishman's China plant now makes intermediates. APIs or bulk drugs are basically the building blocks for drug formulations.

The company had begun constructing the Shanghai facility at the Shanghai Chemical Industry Park way back in 2006, however, regulatory approvals took longer than Dishman had expected, and hence, the facility had been a drain on the company's resources. The company had at one point of time even decided to sell the facility to pare off debt on its books.

In another significant development, Dishman has bagged the license agreement from Johnson Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson Group to produce API for the drug Sirturo (bedaquiline), a medicine used in the treatment of Multi-Drug-Resistant Tuberculosis (MDR TB).

In 2008, Janssen had contracted Dishman to conduct full chemical synthesis of this API at their Bavla facility in Gujarat. Janssen subsequently registered Dishman as a manufacturer of API with the USFDA, European Medicines Agency and several other Asian regulatory authorities.

Dishman has recently started supplying the API to Janssen from its Bavla facility, where it has the capacity to make 5 tonnes of the API per month. At the moment, Janssen is procuring around 2-2.5 tonnes per year from Dishman. Janssen is expected to launch the drug across the globe very soon. Janssen has already registered the drug in 150 countries.

There are around 2.8 million cases of MDR TB worldwide, and as Vyas said, India alone has around 65,000 cases.

While the pricing of the drug is yet to be decided, market sources peg the price for the full course (of six months) ranging between $900-30,000 depending on the country. The price of the treatment would be more in developed nations, compared to that in emerging nations.