Compliance isn't a department at HEXT — it's a company-wide culture embedded in every stage of production.
Hext's manufacturing operations are structured around the Revised Schedule M framework notified under the Drugs and Cosmetics Rules, 1945 (Gazette notification 5 January 2024), which aligns Indian GMP substantially with WHO-GMP, EU-GMP, and USFDA expectations across Pharmaceutical Quality Systems, validation, computerized systems compliance, and data integrity.
This includes structured Product Quality Review cycles, Quality Risk Management protocols, and ALCOA+-aligned documentation across every batch record.
Exporting from India requires a structured submission: a covering letter specifying drug name, dosage form, composition, strength, and destination country; a valid purchase order from the foreign buyer; the manufacturing license for the production site; and, where applicable, an importing-country registration certificate.
Hext's regulatory affairs function is built to manage this documentation chain end-to-end, minimizing time-to-market for new destination filings.
Hext is structured for GeM (Government e-Marketplace) participation, the primary channel for central and state government medicine procurement in India. Government tenders are evaluated on landed price (L1), WHO-GMP and ISO quality compliance, verified drug licensing (Form 20B/21B), supply track record, and delivery-commitment penalty clauses, with price preference extended to MSME-registered vendors.
Hext's quality documentation and licensing posture are maintained to satisfy these technical-qualification criteria continuously, not just at tender submission.
Hext's R&D approach treats formulation science as the primary lever for both efficacy and access — applying pharmacokinetic/pharmacodynamic modeling, stability-indicating analytical methods, and bioequivalence-driven development pathways to every product in the pipeline.
Generic and branded-generic formulation development across essential therapeutic categories for institutional and export supply.
Fixed-dose combination (FDC) science, applying mechanism-of-action compatibility analysis and pharmacokinetic interaction studies to combination products.
Botanical and nutraceutical formulation research, translating traditional medicine compounds into standardized, quality-controlled products with documented stability and bioavailability profiles.
Bioequivalence and stability studies designed to satisfy both CDSCO domestic requirements and destination-market regulatory dossiers.
Product development is supported by structured Site Master Files, validated analytical methods, and documentation systems built for Quality Risk Management review — the same infrastructure examined during WHO-GMP inspections, which typically run three to five days and assess findings across critical, major, and minor non-compliance categories.
Every product is manufactured under strict WHO-GMP compliance with full ALCOA+ traceability and pharmacovigilance readiness.
