Eurofins CDMO

www.eurofins.com/cdmo

#21 & #22 Phase II
Peenya Industrial Area
Bangalore
560058
India

+91 80 6655 2700

Activities

Summary

Eurofins CDMO (Contract Development & Manufacturing Organization) provides integrated, end-to-end solutions for preclinical & clinical outsourcing services for both Drug Substance and Drug Product for Biologicals and Small Molecules.

We can support your drug programs for preclinical studies, formulation screening and development, analytical development and stability studies, non-GMP and GMP sterile and non-sterile manufacturing for IND/ IMPD and NDA/ CTD.

Eurofins CDMO delivers comprehensive solutions to streamline the development and manufacturing of a variety of drug substance and drug products, delivery systems and dosage forms (oral, topical, nasal, injectable).

Profile

Eurofins CDMO, India facility, provides NCE/API development services with pharmaceutical and biotechnology applications for complex, niche, small molecule programs from preclinical to Phase III and commercial manufacturing. To support clinical phase programs, including IND-enabling projects, we offer the following services

  • Scouting of new, innovative and scalable synthetic routes
  • Route development and process safety assessment
  • cGMP manufacturing
  • Polymorph screening & salt selection
  • Analytical method development and validation
  • Stability studies as per ICH

We provide seamless transition from candidate selection to commercialisation. Our Scientists and Process Engineers have excellent experience in developing new, safe and efficient route for complex molecules. Our scientific team is well versed with spike/purge studies, impurity identification, in silico analysis to assess Potential Genotoxic Impurities (PGIs) and developing analytical methods to quantity, process safety studies, polymorph and salt screening and QbD based process development for late phase compounds.

Our team delivers high quality results within defined timelines and ensures highest level of customer satisfaction.

Eurofins CDMO

www.eurofins.com/CDMO
Asia (India) | Europe (Belgium, France) | North America (Canada, USA)

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