10 March 2014 | Interviews | By Rahul Koul Koul
â€œWe are well positioned in Indiaâ€?
Mr Paul A Smaltz, executive vice president-pharmaceuticals, Avantor Performance Materials
After the takeover of New Delhi based biosupplier RFCL's business in 2011, the Avantor Performance Materials, a global supplier of high-performance chemistries and materials to the biopharmaceutical industries, has expanded its footprint significantly in India. Here are the excerpts of the recent interview with one of the company's top executive, Mr Paul A Smaltz.
Q: It has been three years since the acquisition of RFCL by Avantor. How has it benefitted the company operations in India?
The acquisition of RFCL by Avantor has allowed the company to build a solid position in the Indian market as a supplier of high-quality, fully traceable regulated raw materials to the traditional small-molecule market, as well as the growing large-molecule segment.
Thanks to excellent local management and logistics support from the RFCL team, Avantor was able to enter the market as a key supplier of multi-compendia cGMP-produced materials (current Good Manufacturing Practices) by initially importing its JT Baker brand products from the US to supply the fast-growing pharmaceutical market in India.
Avantor then completed a state-of-the-art pharmaceutical raw material facility in Panoli, India, which began cGMP production in January 2013. This facility is ISO 9001:2008 registered; approved by the Indian FDA; and registered with the US FDA.
Avantor now sells its Macron Fine Chemicals brand products with Indian (IP), US (USP), European (EP) and Japanese (JP) Pharmacopeia specifications to major pharmaceutical companies in India out of this facility.
Q: What are your areas of focus as far as product services to bioscience industry is concerned?
Over the last year we have started to supply cGMP buffers out of our facility in Panoli, as well as other inorganic salts that are used throughout the process of manufacturing large-molecule therapeutics and vaccines. We are very excited about the developments in India around the manufacturing of biologics, and this is a big focus for Avantor.
We just launched the JT Baker line of Super Refined polysorbates that enhances stabilization of the API in the finished dosage. This product is being formulated into new biologics as well as small-molecule parenterals with great success.
Q: In Indian context, what are the major challenges and opportunities in the biosupplier business?
Many of the pharmaceutical facilities in India are doing contract manufacturing, or doing runs for clinical trials. This makes it difficult to forecast their demands for raw materials. They need material quickly, with little lead times, to be able to keep to their production schedules. By producing the key processing agents and excipients in India, Avantor is able to respond quickly to the needs of our customers in India.
Q: Please tell us about your interactions with clients in India. Whether there are any new changed trends you witnessed while serving them?
Many Indian companies are producing for the global market now and must upgrade their raw materials and excipients from meeting only IP requirements to also meeting USP, EP and JP requirements, so that their products can be marketed throughout the world. Avantor is uniquely qualified to help our customers in India with this growing need through cGMP-produced materials out of our Panoli plant, which is not only approved by the Indian FDA, but is also registered with the US FDA.
Q: How have your financial results from India been in the last one year? What were the revenues in your last fiscal year? How is the current year expected to be?
As a privately held company, Avantor does not release or discuss financial results publicly, but with the advantages we have through our facility in Panoli we have done quite well. As we get into 2014, we are even more optimistic for our results out of India. Not only do we see significant new business within India as more qualifications are completed with our customers there, but we are now beginning to export product out of India to the rest of the world.
Q: What kind of future outlook do you have for your company, as well as the industry?
We see strong growth. We are well-positioned in India for the growth of large-molecule therapeutics and vaccines. We still see a lot of innovation, not only in the new drug pipeline but in manufacturing processes. The changes in the manufacturing processes affect what raw materials are used and how they are packaged, including pre-weighed buffers and additives in bio bags. Avantor is working with customers across the world to provide products in a more customized format that helps take cost out of the drug manufacturers' processes. As a supplier to the world's leading large-molecule therapeutic manufacturers, Avantor is prepared and committed to help customers in India and around the world to optimize their processes to improve yields and remove costs.