Tablets & Capsules March 2018 47
To be able to export to developed
markets, Indian suppliers must not
only produce excipients that comply
with pharmacopoeial specifications,
they must also manufacture their
products to GMP standards. Indian
suppliers wishing to access this
export market should embrace
quality-by-design and continuous
manufacturing and be prepared to
work with customers to provide the
necessary technical support required
by the developed excipient market.
With the regulatory and quality risks
removed, Indian excipient suppliers
will have a strong opportunity for
growth into the developed US and
European excipient markets. T&C
References
1. http://www.business-standard.
c o m / c o n t e n t / b 2 b - p h a r m a / n o v e l
-drug-delivery-system-is-driving-the
-demand-for-innovative-excipients
-114081901422_1.html
2. http://www.klinegroup.com/
news/oral_solid_dosage_form_excip-
ients.asp
3. https://www.in-pharmatechnologist.
com/Article/2014/04/30/Emerging
-excipient-markets-to-outpace-Western
-markets-report-says
4 . h t t p : / / w w w . g n a i p r . c o m /
Articles/Gireesh%20Babu.pdf
5. http://ipec-europe.org/news
letter.asp?nlaid=776&nlid=56
6. http://www.in-pharmatechnologist.
com/Ingredients/Nitika-to-build-4th
-excipients-plant-near-emerging-Indian
-export-hub
7. https://www.europeanpharma
ceuticalreview.com/news/43490/acg
-acpl-asia-excipact-certification/
8. http://www.pharmabiz.com/
PrintArticle.aspx?aid=85629&sid=2
9. http://www.pharmabiz.com/
NewsDetails.aspx?aid=81645&sid
=2References
10. http://www.jrspharma.com/
pharma_en/india/local-manufacturing.
php
11. http://www.foodingredients-
first.com/news/Roquette-Begins-Joint-
Venture-With-Riddhi-Siddhi-to-
Become-Leading-Starch-Company-In-
India.html?keepThis=true&TB_iframe
=true&height=425&width=800
Kirti Vatsa is lead procurement analyst,
specializing in contract manufacturing
-drug formulations and excipients at
Beroe (www.beroeinc.com). She is
responsible for end-to-end project
management and has been involved in
more than 150 successful project
d e l i v e r i e s . F o r m o r e i n f o r m a t i o n ,
contact: info@beroe-inc.com.
• In 2014, Colorcon Asia invested
INR 70 crore to expand its Goa
facility dedicated to film coatings [9].
• In 2015, Sudeep Pharma entered
into a joint venture with JRS Pharma
to produce calcium-based phosphates.
As previously discussed, JRS Pharma
has already had a joint venture with
Gujarat Microwax for more than 10
years to produce MCC [10].
• In 2012, Roquette Pharma
acquired three corn-starch production
sites from Riddhi Siddhi Gluco Biols,
based in Ahmedabad [11].
Conclusions
Within 5 years, India is likely to
become a prominent region for
excipient manufacturing, and the
export market share to the US and
Europe should increase by at least 10
percent. Global pharmaceutical
companies will likely prefer to enter
into agreements with either global
suppliers that have a regional
presence (local manufacturing) or
domestic Indian GMP-qualified
suppliers with no regulatory risks.
T h e n u m b e r o f t o p e x c i p i e n t
suppliers entering into joint ventures
with Indian suppliers should increase
at a faster pace during the next five
years. These joint ventures will
continue to help global excipient
suppliers widen their geographical
reach and provide local Indian
suppliers with the means to upgrade
their facilities to meet the demands
of global pharmaceutical customers.
