We are a dedicated 100% API provider with our regulatory compliant services focussed on the singular objective of meeting the API requirements of generic and innovator pharmaceutical companies.
Generic Drug Substances
Engaged in the manufacturing of non-exclusive APIs, which are supplied to the leading generic pharmaceutical companies globally.
The vertical has two segments: Prime APIs - comprising large volume, mature molecules, and Specialty APIs – comprising lower volume, complex molecules with less competition.
Strengths
We have earned the identity of a preferred and reliable API supplier in the pharmaceutical industry due to our consistency in product quality, knowledge and ability to deal with niche chemistry, and on-time delivery performance.
Custom Manufacturing Solutions
Engaged in the custom development and manufacturing of New Chemical Entity (NCE) APIs for pharmaceutical and biotech companies bringing new innovations to the market.
We help handle a range of chemistry services from pre-IND through manufacturing that includes small-scale clinical trial quantities as well as full-scale commercial supplies with minimal tech transfer timelines.
Strengths
Our deep understanding of complex chemical processes and manufacturing has enabled us to build a strong track record in delivering custom manufacturing solutions. We are supported in our efforts by our state-of-the-art R&D centre and cGMP-compliant manufacturing facilities.
| Business Vertical | Generic Drug Substance | Custom Manufacturing Solutions |
| Solutions | Development and manufacturing of
non-exclusive APIs
PrimeSpecialty |
Exclusive contract development and manufacturing of NCE APIs |
| Revenue Share | 32% 27% |
37% |
| Customers | Generic companies |
Innovators |
| Achievements |
950+DMFs filed 3 New DMFsfiled in FY 2023 300+API processes developed 204patents filed |
Several NCE APIs added in NDA Support for multiple APIs each year in |
Quality Standards
15 US FDA inspections cleared
US FDA (USA)
Unit-1 Inspection
March 1997, May 2004, March 2008 (PAI for NDA),
November 2010, April 2014, April 2017, June 2019
Unit-2 Inspection
June 1999, February 2002, November 2005, September 2012,
August 2015, November 2018, February 2020
R&D Inspection
February 2016
EDQM (Europe)
Unit-1 Inspection
December 2005
Unit-2 Inspection
June 2017
PMDA (Japan)
Unit-1 Inspection
October 2008
Unit-2 Inspection
October 2008
ANVISA (Brazil)
Unit-1 Inspection
March 2012, May 2014
Unit-2 Inspection
April 2011, May 2013, May 2016
Unit-3 Inspection
February 2022
WHO GMP
Unit-1 Inspection
February 2018
EMA (Europe)
Unit-1 Inspection
January 2013
KFDA/MFDS (South Korea)
Unit-1 Inspection
February 2010, July 2014
Unit-2 Inspection
February 2012
COFEPRIS (Mexico)
Unit-1 Inspection
February 2014
Unit-2 Inspection
February 2014
FSI “SID&GP” (Russia)
Unit-1 Inspection
February 2019
BfArM (Germany)
Unit-1 Inspection
February 2007
SFDA/CFDA (China)
Unit-1 Inspection
December 2017
ISO 14001:2015
Unit-1 Inspection
November 2022
Unit-2 Inspection
November 2022
Unit-3 Inspection
November 2022
Empty
R&D is
ISO 14001:2015 Certified
in November 2022
AFSSAPS /ANSM France)
Unit-1 Inspection
February 2012
TGA (Australia)
Unit-1 Inspection
April 2011
ISO 45001:2018
Unit-1 Inspection
November 2022
Unit-2 Inspection
November 2022
Unit-3 Inspection
November 2022
Empty
R&D is
ISO 45001:2018 Certified
in November 2022
Our Infrastructure
