Issue link: https://www.e-digitaleditions.com/i/947832
44 March 2018 Tablets & Capsules Excipient manufacturing in India While India is a dominant global presence for API manufacturing, the country is not a mature market for excipient manufacturing. As with API sourcing, the advantage of sourcing excipients from India is the cost benefit. India produces commodity excipients such as starch, gelatin, and capsules in adequate supply, but they are primarily consumed by the domestic Indian market. It's estimated that only 10 percent of excipients manufactured in India are currently being used in the US and Europe. In the last 4 or 5 years, this has begun to change. The Indian excipient market has seen an increase in the number of Indian Drug Master File (DMF) holders, an increase in the export growth rate of several major excipients, and an increased interest by Indian suppliers in expanding export capacity to developed markets. Because of these changes, which I will discuss in more detail in the following sections, the Indian excipient market is expected to grow 10 to 12 percent annually through 2020. Increasing number of Indian DMF holders. To avoid regulatory c h a l l e n g e s f o r e x p o r t s , g l o b a l excipient suppliers must invest in local suppliers to upgrade their m a n u f a c t u r i n g f a c i l i t i e s . T h i s generally involves submitting a DMF to the US FDA. The percentage of Indian pharmaceutical companies that are DMF holders for excipients has increased from 7 percent in 2011 to 13 percent in 2017. Figure 1 shows the major Indian excipient suppliers and the number of DMFs held by each. The top excipients supplied by major suppliers such as Corel Pharma Chem, Ideal Cures, Hindustan Phosphates, and Crest Cellulose are pharmaceutical coatings, phosphates, and MCCs, respectively. Between 2012 and the second quarter of 2017, there were 119 new DMF certifications in India for pharmaceutical excipients, as shown in Figure 2. The highest number of certifications were for excipients such as cellulose, capsules, coatings, and calcium phosphate because of their high market demand and wide usage in co-processed excipients. Increasing exports of major excipients. Some excipients, including MCC and croscarmellose sodium, are currently being sourced from India to developed markets, but Indian pharmaceutical companies primarily rely on imports from the US, Europe, and Japan for more expensive e x c i p i e n t s s u c h a s p o v i d o n e , crospovidone, polyethylene glycol (PEG), as well as a few cellulose- derived excipients. However, as global demand increases, global suppliers will also increase production capacity in emerging markets such as India, either by establishing joint ventures or acquiring local suppliers with smaller product portfolios. For example, a joint venture between JRS Pharma and Gujarat Microwax to manufacture MCC products has been in place for nearly 10 years. In 2009, the companies also commissioned a new disintegrant plant, which has helped JRS Pharma expand its disintegrant product line and double its capacity. In 2011, DFE Pharma acquired Brahmar Cellulose, a Cuddalore- based excipient supplier, which has Figure 1 Major DMF-holding Indian excipient suppliers 12 10 8 6 4 2 0 Number of DMFs Supplier Dhara Lifescience Corel Pharma Chem Ideal Cures ACG-Associated Capsules Vikram Thermo Hindustan Phosphates Crest Cellulose 11 10 6 6 5 5 4 Source: US DMF list Figure 2 New Indian pharmaceutical excipient DMF certifications (2012-2017*) 60 50 40 30 20 10 0 Number of DMFs Year 2012 2013 2014 2015 2016 2017 4 7 51 18 11 28 Source: US DMF list *through second quarter 2017