Laborate Pharmaceuticals India Ltd. today announced that its Paonta Sahib manufacturing facility in Himachal Pradesh has received WHO Prequalification (WHO-PQ) status for three additional essential medicine formulations. The newly approved products — Artemether + Lumefantrine Tablets 20/120mg, Co-trimoxazole Tablets 400/80mg, and Paracetamol Tablets 500mg — span antimalarial, anti-infective, and analgesic therapeutic categories. This milestone brings the total number of WHO-prequalified formulations in the Laborate portfolio to nine.
The achievement enables Laborate to supply these formulations to United Nations agencies including UNICEF and UNDP, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and government health authorities conducting procurement under the WHO Essential Medicines Model List framework. The expansion of the prequalified portfolio directly positions Laborate to serve public health programmes across 35 countries in Sub-Saharan Africa, Southeast Asia, and Latin America.
Our WHO-prequalification achievements are not milestones in isolation — they are the direct result of decades of investment in systems, infrastructure, and talent that delivers pharmaceutical quality at international standards. This expansion is a validation of our commitment to making quality-assured medicines accessible in the markets that need them most.
Three-Year Regulatory Programme
The WHO Prequalification achievement follows a structured three-year programme of facility upgrades, quality system enhancements, and regulatory dossier submissions carried out in partnership with the WHO Prequalification Programme. The programme involved:
- Comprehensive upgrade of the oral solid dosage manufacturing block at Paonta Sahib, including new automated granulation, blending, and tablet compression equipment to EU-GMP specification;
- Development and validation of WHO-PQ compliant dossiers for all three formulations, including full stability data packages, analytical method validations, and bioequivalence studies conducted at accredited CROs in India and Europe;
- Successful site inspection by a WHO inspection team in February 2026, resulting in a Satisfactory outcome across all critical quality systems including documentation, environmental monitoring, cleaning validation, and quality control laboratories;
- Registration and confirmation of supply chain provenance for all active pharmaceutical ingredients (APIs) sourced from WHO-approved or ICH-compliant API manufacturers.
Nine WHO-prequalified formulations. Thirty-five countries. One uncompromising standard of pharmaceutical quality — built into every process, every batch, every inspection.
— Laborate Quality Affairs Leadership Team
Manufacturing Facility Profile
The Paonta Sahib facility — situated in the Sirmour district of Himachal Pradesh — is Laborate's primary site for regulated market manufacturing. The facility holds WHO-GMP certification, EU-GMP approval for its sterile injectable production block, and USFDA approval for its active pharmaceutical ingredient manufacturing unit. The site produces over 2.8 billion dosage units annually across oral solid, liquid, and injectable pharmaceutical forms.
Impact on Global Health Programmes
WHO Prequalification is the standard most widely relied upon by international procurement agencies as evidence that a pharmaceutical product meets international standards of safety, efficacy, and quality. For low- and middle-income countries where domestic pharmaceutical regulatory capacity may be limited, WHO-PQ provides the assurance required for inclusion in national essential medicines procurement programmes.
The three newly prequalified formulations address therapeutic categories where access gaps in LMICs are most critical: malaria (Artemether + Lumefantrine), bacterial infections (Co-trimoxazole), and pain and fever management (Paracetamol). Combined with Laborate's existing six prequalified formulations, the expanded portfolio now covers six of the ten most-procured essential medicine categories under WHO/UNICEF supply frameworks.
Laborate has been a registered WHO-PQ supplier since 2021, when its first three formulations — Amoxicillin Trihydrate Capsules 250mg, Metformin HCl Tablets 500mg, and Atenolol Tablets 50mg — received prequalification. The addition of the three new products reflects a deliberate product development strategy aligned with WHO Essential Medicines priorities, developed in close consultation with the company's global health and export affairs team.
