Certification
WHO-Prequalified CDMOs
Compare CDMOs with WHO prequalification for participation in UN procurement and global health programs. Filter by product type and manufacturing capabilities.
44 companies listed
About WHO Prequalification
WHO Prequalification (PQ) is a quality assurance program that evaluates pharmaceutical products and manufacturers to ensure they meet international standards. Products and facilities that achieve WHO PQ status are eligible for procurement by UN agencies (UNICEF, UNDP), the Global Fund, GAVI, and other international organizations. This is the gateway to supplying medicines for global health programs.
WHO prequalification involves both product assessment (quality, safety, efficacy) and manufacturing site inspection (GMP compliance). The standard is aligned with PIC/S GMP guidelines. CDMOs with WHO PQ status have demonstrated compliance with international quality standards and can supply products for donor-funded procurement programs serving low- and middle-income countries.
Companies (44)
AMN Life Science Pvt Ltd
India
AMN Life Science Pvt Ltd is an Indian pharmaceutical company headquartered in Mumbai, engaged in pharmaceutical product development and manufacturing of formulations for international markets. The company manufactures a range of oral solid dosage and oral liquid products across therapeutic areas including gastrointestinal, antibiotics, and nutraceuticals, with EU GMP and WHO cGMP certifications.
Oral Solid DoseFormulation DevelopmentSolid Dose Manufacturing
Aurobindo Pharma (incl. Eugia/Generis)
India
Aurobindo Pharma Limited is one of the world's largest vertically integrated generic pharmaceutical companies, headquartered in Hyderabad, India, operating 29 manufacturing facilities globally with capacity to produce 50+ billion formulation units and 19,000+ MT of APIs annually. Through subsidiaries Eugia Pharma Specialities (sterile injectables, oncology), CuraTeQ Biologics (biosimilars), and TheraNym Biologics, Aurobindo operates as a major CDMO. The company holds 830 US ANDA filings with 600+ approvals, and has manufacturing and packaging facilities across India, the US, Portugal, Brazil, and China. CuraTeQ received EMA GMP certification in 2024 for mammalian and microbial drug substance production, prefilled syringe and vial filling. Aurobindo's CDMO expansion includes a contract with MSD for biologics manufacturing with 15,000L bioreactors and 25-30 million vial annual capacity.
Frequently Asked Questions
What is the difference between WHO prequalification and FDA approval?+
FDA approval authorizes marketing of a specific drug product in the US market. WHO prequalification assesses whether a product and its manufacturer meet international quality standards for procurement by UN agencies. They are separate processes with different assessors. Some products carry both. The WHO PQ process evaluates the manufacturing facility's GMP compliance similarly to FDA, but the product assessment focuses on demonstration of interchangeability with the originator product.
Which products commonly require WHO prequalification?+
WHO prequalification is most common for: HIV/AIDS antiretrovirals, antimalarials, tuberculosis medicines, reproductive health products, vaccines (including COVID-19), and certain diagnostics. These product categories align with the major global health procurement programs. CDMOs manufacturing these products benefit significantly from WHO PQ status as it opens access to large-volume procurement tenders.
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