Our Quality Standards
We believe transparency builds trust. Here is a complete, unambiguous explanation of how we qualify suppliers, verify certifications, and ensure every product meets the highest international pharmaceutical standards before it ships to your door.
Certifications We Require from Every Supplier
No exceptions. Every manufacturer in our supply chain must hold and maintain the following certifications to remain approved.
WHO-GMP Certification
World Health Organization Good Manufacturing Practice certification, granted after on-site inspection covering facilities, equipment qualification, process validation, quality control laboratories, and documentation systems. Must be current (within 3 years).
US FDA Site Registration
Manufacturers supplying products for US consumption must be registered with the US FDA under 21 CFR Part 207 (drugs) or 21 CFR Part 1 (facilities). We verify current FDA registration status and check for any active Import Alerts or Warning Letters via the FDA's public database before supplier approval.
Third-Party Certificate of Analysis (CoA)
Every batch must ship with a Certificate of Analysis from an accredited third-party laboratory confirming identity, assay (potency), purity, microbial contamination limits, and heavy metal levels. We maintain CoA records on file for a minimum of 5 years.
ISO 9001:2015 Quality Management
ISO 9001:2015 certification demonstrates a systematically implemented Quality Management System (QMS) with documented procedures, management review, continuous improvement, and customer satisfaction measurement — a foundational requirement for pharmaceutical-grade operations.
21 CFR Part 111 (Supplement Suppliers)
For our Ayurvedic and dietary supplement products, suppliers must comply with 21 CFR Part 111 — the US FDA's Current Good Manufacturing Practice regulations for dietary supplements — covering manufacturing operations, holding, packaging, labeling, and distribution.
Pharmacopoeial Compliance
Active Pharmaceutical Ingredients (APIs) must meet United States Pharmacopeia (USP) or European Pharmacopoeia (EP) monograph specifications for identity, assay, and impurity profiles. Finished products are compared against reference standards from the US FDA's Orange Book where applicable.
Our 5-Stage Supplier Qualification Process
No manufacturer becomes a GlobalIndia Pharmacy supplier without passing each of these five stages.
Documentation Review
Collection and verification of all regulatory certificates: WHO-GMP certificate, FDA registration number, ISO 9001 certificate, current Good Manufacturing Practice compliance statements, and any recent inspection reports or Establishment Inspection Reports (EIRs) from the US FDA.
Regulatory Database Cross-Check
Direct verification against the US FDA's public databases: FDA's Registered Drug Establishments list, the Import Alert database (to screen for any 66-40 or 66-41 alerts), and the Warning Letter database. No supplier with an unresolved Import Alert is approved.
Sample Testing & Analytical Verification
Pre-qualification samples are tested by an independent, ISO 17025-accredited analytical laboratory. Tests performed include: identity (HPLC/IR), assay/potency, related substances, microbial limits, heavy metals (ICP-MS), and, for herbal products, pesticide residue screening. Results must match the supplier's submitted CoA within acceptable limits.
Quality Agreement Execution
A formal Quality Agreement is executed with each approved supplier, defining responsibilities for change control, deviation reporting, recall procedures, stability data provision, and the supplier's obligation to notify us of any regulatory actions or manufacturing changes that may affect product quality.
Ongoing Periodic Monitoring
Approved suppliers are subject to annual re-qualification reviews, FDA database monitoring for new regulatory actions, and periodic surprise batch retesting by our independent laboratory. Supplier status is immediately suspended if an Import Alert, Warning Letter, or voluntary recall is issued.
India's Place in Global Pharmaceutical Quality
India's pharmaceutical industry is not simply a low-cost alternative — it is one of the most rigorously regulated and internationally integrated manufacturing ecosystems in the world. The country is the world's largest producer of generic drugs by volume and a dominant supplier to the United States, European Union, United Kingdom, and over 200 countries.
India's pharma exports are subject to continuous oversight from the US FDA, European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (UK MHRA), and other stringent regulatory authorities. Major Indian manufacturers like Sun Pharma, Dr. Reddy's, Cipla, Lupin, Aurobindo, and Zydus Cadila supply products to US health insurance formularies, Medicaid, and Veterans Administration programs.
Read Our Full Generics Science Guide500+
US FDA-approved Indian manufacturing facilities
40%
of US generic prescriptions contain Indian-made drugs
200+
countries receive Indian pharmaceutical exports
$27B+
annual Indian pharma export value (2024)
Quality You Can Trust. Prices That Make Sense.
Browse our curated range of WHO-GMP certified generics and GMP-compliant Ayurvedic supplements — all backed by our 5-stage supplier quality process.
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