A quality officer sampling a sack of raw material at intake, Dehradun

Quality without exception.

End-to-end quality aligned with European pharmaceutical benchmarks, the same rigour applied to nutraceutical ingredients as to regulated pharmaceutical actives, with the dossiers to evidence it.

Quality & Compliance

What the systems actually cover.

Eight certifications and dossier systems, and what each one covers.

Manufacturing

WHO GMP-COPP

Good Manufacturing Practice certification under the WHO scheme, the global benchmark for pharmaceutical-ingredient supply.

Quality Systems

ISO 9001:2015 · ISO 22000:2018

Dual certification covering quality management and food-safety management across nutraceutical and pharmaceutical operations.

European Compliance

EU-GMP / CEP

Sitewide EU-GMP audit passed; Certificate of Suitability granted by the EDQM for Thiocolchicoside and Colchicine.

Food Safety

HACCP Certified

Hazard Analysis and Critical Control Points, a systematic preventive approach to safety across all ingredient processing.

Market Access

Halal · Kosher

Third-party Halal and Kosher certification across the portfolio, supporting global market access.

Data Integrity

21 CFR Part 11

Compliance with the FDA 21 CFR Part 11 requirements for electronic records and data integrity.

Regulatory Dossiers

DMF / EDMF on File

Drug Master Files and European DMFs on record, enabling direct regulatory-submission support for US, EU and global markets.

Extraction Standard

Extraction by Specification

Extraction is selected by active and specification, including supercritical CO₂ and controlled green-solvent extraction, with residual-solvent testing against the applicable specification on every lot.

At Dehradun

Where the release decision is made.

Every lot is analysed on site before it ships. The same laboratory releases nutraceutical ingredients and regulated pharmaceutical actives, against the same systems and the same data-integrity controls.

Analysts at work in the quality control laboratory
Quality control laboratory
High-performance liquid chromatography in the quality control laboratory
HPLC · assay
The clean room suite at the Dehradun facility
Clean-room suite
Air shower at the entrance to the controlled sampling area
Controlled sampling area

Talk to our team.

Samples, specifications and dossiers.