COMPANY PROFILE
- Biopharmaceuticals (Active Pharmaceutical Ingredients)
- Finished Dosage Formulations
- R&D (API & Finished Formulations)
- Contract Research & Manufacturing
QUALITY / ACCREDITATIONS
Concord Biotech complies with cGMP norms & is accredited by Global Regulatory Authorities like
- USFDA
- EU GMP
- Japanese AFM
- State GMP
- R&D Recognition by DSIR India
OUR EXPERTISE
Development & Commercialisation of niche complex fermentation & semi-synthetic Biopharmaceutical products.
- Scale –Up from Laboratory to Commercial Scale
- Process Optimization & Yield Improvement
- Development of niche Finished Dosage Formulation
- ANDA/ eCTD/ Dossiers filling for product registration as per Regulatory Authorities requirements
R&D is a key growth driver for Concord. We have dedicated R&D units for API’s & Formulation both of which are approved by DSIR (Department of Scientific and Industrial Research),India. Concord’s experienced research team has developed & Commercialised several niche Biotechnology products & complex finished formulations. We also offer Contract Research & Manufacturing services in the area of fermentation, semi-synthetic products & finished formulations.
Quality is the prime focus at Concord Biotech . The quality management system encompasses three distinct departments namely Quality Control, Quality assurance and Regulatory.
The manufacturing facilities at Concord Biotech are at par with the best in the world with our state-of-the-art infrastructure, world-class technology and strict adherence .
VISION
Create products through Biotechnology route and service offerings that enrich the lives of people by continually building on our expertise in Biotechnology.
MISSION
We strive to be a global power in the field of Biotechnology based products through research and development to create sustainable earnings growth and to establish long term business success.
PHARMACOVIGILANCE AND REPORTING OF ADVERSE EVENTS
Concord monitor safety and constantly assess the benefit-risk profile of its products in close relation with health authorities.
We are an environment conscious organization and our process framework includes responsibilities such as environmental management and implementation of optimal methods and measures for its preservation. As a responsible corporate, Concord has always believed in taking all the necessary precautions to help maintain the balance of our Eco-system.
Concord believes that along with sustained economic performance, environmental and social stewardship is also a key factor for holistic business growth. We strive to integrate our business values and operations to meet the expectations of our stakeholders.
- 1st USFDA Inspection of the Formulation facility successfully completed in July 2017
- Concord participated in various National and international conferences of medical fraternity in the promoted segment of Nephrology & organ transplantation in India as well as Industrial exhibition globally.
- CRAM projects initiated with a Global Biopharmaceutical Company in the area of Natural Products.
- Launched Domestic Business Operation into super specialty segments like Immunology, Organ Transplantation & Chronic Kidney Disease segment by forming a business unit “INTRA”
- Concord Biotech signs MoU with Gujarat Government at Vibrant Gujarat Summit 2017
- Concord Biotech Limited ranked 14 in the Biospectrum 2016 survey of top Indian Biotech Companies
- 2nd USFDA Inspection of Formulation facility successfully completed with Zero 483’s in February 2018
- Expansion of Oncology block to meet growing market demand
- WHO-GMP Inspection of Formulation facility successfully completed in November 2017
- 5th USFDA Inspection of API facility successfully completed with Zero 483 observations in November 2017
- 3rd EUGMP inspection of API facility successfully completed in September 2017