- State-of-the art R&D facility with world-class equipments and helmed by highly skilled scientists- a perfect platform to develop biosimilars with top notch QSE[Quality Safety & Efficacy] profiles.
- Biosimilars developed following Quality by Design[QbD] based approach to achieve well-characterized process and desired Critical Quality Attributes[CQA].
- Hetero’s platform technology enables a quick turnaround time for the development of new biosimilars.
- Biologics manufacturing facility majority deploys single-use and state-of-the-art equipments from reputed companies. It is also built and operated to comply with the cGMP standards of various regulatory agencies.
- State-of-the-art facility has been successfully audited and inspected by WHO-GMP and PIC/S member countries viz SMDC-Ukraine, NPRA-Malaysia, TMMDA-Turkey, TFDA-Thailand, COFEPRIS - Mexico, ANMAT - Argentina.
- Also approved by INVIMA - Colombia, ISP - Chile, PPB - Kenya, NMRA - Srilanka, FDA - Tanzania, FDA - Philippines, DDA - Nepal, FMHACA - Ethiopia, NAFDAC - Nigeria, DIGEMID - Peru , NDA - Uganda, ZaZiBoNa, MoH - Syria and other agencies.
- Fully integrated facility with best in class single-use process systems in both upstream and downstream.
- Manufacturing facility for both drug substance and drug product with enough capacity to manufacture and cater to large markets, with ample scope for expansion.
Regulatory Affairs & Clinical Expertise
- Capable of providing CTD and e-CTD forms of dossiers as per ICH and other major international formats.
- Clinical Development and Medical Affairs[CDMA] team supports clinical evaluation from phase I to IV, in compliance with global regulatory requirements and also support pharmacovigilance programs.
- An exclusive project team with hands-on experience in successful transfers of different models of technology with constant support from planning to execution to various geographies.
- Project team with immense experience in the regulatory strategic planning to run the technology transfer projects in line with local regulatory requirements for successful registration of the product.
Global Business Operations
- Our global business team has through understanding of the commercial pathways for biosimilars, thereby enabling us to overcome to entry barriers for early commercialisation.
- Flexible business model defines our passion of taking complex biosimilars across emerging markets.
- Initiated entry to regulated markets through strategic partnerships.