Every PNS product is the outcome of a quality system engineered from the molecule up. Cleanroom architecture, validated processes, multi-stage sterilisation, and exhaustive documentation — quality isn't a checkpoint here. It's the entire blueprint.
— Certifications
World Health Organization GMP guidelines — the international benchmark for pharmaceutical manufacturing. Validated processes for global market access.
Internationally recognised QMS certification. Continuous improvement, risk-based thinking, and customer-focused process governance.
Compliance with Schedule M of the Indian Drugs & Cosmetics Act — India's mandatory GMP framework with international harmonisation.
All formulations comply with the Indian Pharmacopoeia testing protocols — purity, sterility, pyrogenicity, particulate matter standards.
Licensed and regulated by India's apex drug authority. CDSCO oversight ensures compliance at every production milestone.
WHO-format CoPP available for export markets — accelerating in-country product registration and ministry of health approvals.
— Quality Process
Five rigorous stages. Multiple checkpoints. Zero shortcuts.
Every API and excipient batch is tested on arrival — identity, purity, microbial load, endotoxin levels — against IP standards.
Real-time monitoring of fill volume, pH, conductivity, and visible particulates throughout the production cycle.
Validated moist-heat sterilization cycles ensure absolute sterility assurance level (SAL ≤ 10⁻⁶).
Sterility, pyrogen, particulate matter, leak integrity — every batch tested before any unit is released.
Independent Quality Assurance review of complete batch records before formal release for distribution.
— Manufacturing Infrastructure
Our Kanpur facility is purpose-built for sterile IV production. Cleanroom architecture follows ISO 14644 standards, with HEPA-filtered air, controlled differential pressure cascades, and strict gowning protocols.
— Documentation Available
In regulated markets, documentation is product. Our regulatory affairs team prepares complete export packs tailored to your in-country requirements.
Request Documentation Pack →— Documentation Requests