Five minutes at Informex with

Ajay Ohri, VP business development – CRAMS USA at Navin Fluorine International

PH: The company has recently announced some expansion at its GMP site in India. Can you give some further details?

Ohri: We are currently increasing the vessel size in our facility, adding two large vessels. There are further discussions with the board to come on expansion. We hope they will approve, because as the pipeline increases, we want to make sure we are able to fulfil the capacity. Hopefully by the end of next year we will have a third facility, all on the same site. This is a 48 acre [19.4 hectare] site at Dewas in Madhya Pradesh state, of which we have only used ten acres. We are hoping for some good news by the middle of this year.

PH: What has driven the expansion?

Ohri: The growth of our business and the demand created in the marketplace. A lot of molecules are moving into Phase II and III and this is another reason why companies are investing more, plus the R&D budgets that these companies are putting in – they are looking for some unique molecules and technologies and I think we are there at the right place and time to come in and solve those problems.

PH: How is business for Navin Fluorine generally?

Ohri: Navin has four business units. I am responsible for CRAMS in the North America market, which is doing really well. The difference from when I started six years ago is like day and night. In the last few years, the numbers have basically doubled. We expect to hit our targets this year. Manchester Organics, our UK subsidiary, is a very strategic investment, it gives us a port of entry where we do a lot of small-scale, multi-kilo work, but the key gap it fills is the tech transfer that happens in India.

PH: What else do you bring to the table?

Ohri: We are one of very few GMP fluorinating facilities that provides the key starting materials and intermediates. The FDA is now encouraging the industry to maintain records and impurity profiles from the get-go. Even if companies are not looking for GMP materials, they may need the batch records and we can provide that. The cost factor in that is basically negligible until the client requires GMP. Quality controls are much tighter in that environment, which is something the client appreciates and that’s another reason we get repeat business. Other growth drivers for us are high pressure chemistry and hydrogenation, which are core technology of ours, and the growing vessel sizes. Our investment in PRD is significant and that is becoming our core competency as we grow our business. We are planning to double the size of this group by the end of 2017.

PH: Some people are now looking at putting hydrogenation through continuous flow reactors. Are you?

Ohri: We are looking at using it for making SF₄, which we use a lot of as it is a fluorination reagent. Some initial results have been very positive. HF is another candidate that we make in-house, also BF₃ and Xtalfluor, another fluorination reagent which we are the exclusive manufacturers of. Generally, we are seeking to expand and diversify our chemistry. Fluorine is only one part of that.

PH: There have been some high-profile actions by the FDA against Indian companies in the past year. Has this impacted you?

Ohri: Not really, because we don’t make any API. Our technology is very niche and companies have to be very careful of the environment, the US is not going to do anything with HF. From that perspective, we have tremendous opportunities for growth. In fluorination and hazardous chemistries, a different level of expertise is required, in scalability, in process and in managing the equipment. Very few companies have the expertise to do that.