Every Approval.
Every Market.

One of a handful of manufacturers globally to hold a Certificate of Suitability from EDQM for CHG 20%. This certification confirms compliance with the European Pharmacopoeia monograph and enables supply to all EU member states without additional analytical dossiers.

Garonit's Accreditation of Foreign Drug Manufacturer (AFM, No. AG30400717) from Japan's PMDA authorises our manufacturing facility to produce drug substances for the Japanese market. This facility-level accreditation is a prerequisite for supplying active pharmaceutical ingredients into Japan.

Our Japan Drug Master File (DMF Registration No. 305MF10128) is product-specific to 20% Chlorhexidine Digluconate Solution, enabling its use by pharmaceutical manufacturers in the Japanese market — one of the most stringent regulatory environments globally.

A Written Confirmation certifies that our active substance is manufactured to GMP standards equivalent to those required in the European Union, as mandated for importing APIs into the EU under Directive 2001/83/EC. It enables supply of our active ingredients to EU-based pharmaceutical manufacturers.

ISO certification of our India manufacturing subsidiary underpins the quality management system governing all production, testing, and supply chain operations.

REACH registration enables Garonit to supply chemical substances into the European Union without restriction, confirming full compliance with safety, health, and environmental data requirements.

Garonit is listed on the ECHA Article 95 list for Biocidal Products Regulation (BPR), covering human hygiene biocides (PT1), private and public health disinfectants (PT2), and veterinary hygiene (PT3). This listing is required to legally supply active substances for biocidal use in the EU.

ISO 14001:2015 certification confirms a structured environmental management system governing resource use, emissions, waste, and continual environmental-impact improvement across our manufacturing operations.

ISO 45001:2018 certification establishes an occupational health and safety management system that protects workers, reduces workplace risk, and drives continual safety-performance improvement.

Halal certification confirms that applicable products and processes meet Halal requirements, enabling supply to Halal-regulated markets across the Middle East, South-East Asia, and beyond.

Local State FDA manufacturing license authorising pharmaceutical API production at our India facility, complementing CDSCO oversight and our international regulatory registrations.

Garonit's US FDA Drug Master File (DMF No. 21946) establishes the regulatory foundation for CHG 20% supply into the US market. The DMF is routinely inspected and maintained in full compliance with 21 CFR Part 312.

Garonit holds a Korean Drug Master File (KDMF) registration for 20% Chlorhexidine Digluconate with the Korea Ministry of Food and Drug Safety (MFDS), filed under the Pharmasol name. This registration enables supply of our CHG 20% into the South Korean pharmaceutical market.

WHO Good Manufacturing Practice certification for our India facility (Garonit Pharmaceutical Pvt. Ltd.) confirms that the plant meets international pharmaceutical manufacturing standards for APIs supplied to global markets.

US EPA registration covers the antimicrobial and disinfectant product applications of our ingredients, enabling commercial supply for regulated institutional and industrial disinfectant formulations in the United States.

All manufacturing facilities — Flanders, NJ and Fairfield, NJ (USA) and India — operate under current Good Manufacturing Practice (cGMP) standards. Procedures, equipment, and quality systems are audited to the same standard regardless of location.

Garonit's APIs — in particular Chlorhexidine Gluconate 20% — comply with all major international pharmacopoeia monographs: the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP).