Formulation Rigor & WHO-GMP Quality.
At Galcare, quality is not a static check—it is our identity. From sourcing top-grade API makes to manufacturing in our 2023 WHO-GMP certified plant in Rajasthan, we ensure precision in every dose.
State-of-the-Art Formulation Plant in Rajasthan
In 2023, Galcare commissioned its own WHO & GMP certified manufacturing facility in Rajasthan. Built to modern pharmaceutical standards, the plant houses automated manufacturing lines for creams, gels, ointments, lotions, and specialized oral formulations.
Multi-Stage Quality Checking Gates
We monitor formulation parameters across four stringent QC gates to guarantee zero-defect batch uniformity.
1. API & Raw Material Assay
Rigorous analytical testing of Active Pharmaceutical Ingredients (APIs) and excipients upon receipt. Verifying purity, assay percentages, and particle size distribution before batch formulation.
2. Chemical & Physical QC
In-line monitoring of formulation pH, viscosity, emulsification stability, density, and rheology in real-time during mixing and filling stages.
3. Microbiological Sterile Assays
Culturing in cleanroom chambers to guarantee zero bacterial or fungal bio-burden. Validating preservative efficacy for multi-use topical creams and lotions.
4. Post-Market Stability Retention
Retaining reference batch samples in ICH-compliant climate chambers (25°C/60% RH & 40°C/75% RH) to verify shelf life stability over 24 to 36 months.
Certifications & Global Compliance
Our manufacturing and quality systems undergo rigorous periodic audits by health authorities.
WHO-GMP Certified Plant
In-house formulation unit in Rajasthan certified under World Health Organization Good Manufacturing Practices.
ISO 9001:2015 Standard
Certified Quality Management Systems ensuring standardized SOPs across production, packaging, and dispatch.
GLP Compliant Laboratories
Good Laboratory Practices observed in our chemical analysis and microbiological testing chambers.
DCGI & Regulatory Filings
All formulations comply with Drug Controller General of India (DCGI) guidelines and stability requirements.