Manufacturing
Our cGMP
Manufacturing Network
Headquartered in Flanders, New Jersey, with a dedicated CHG facility in Fairfield, NJ and a WHO-GMP plant in India — every site audited to the same uncompromising standard.
Headquarters & Primary Facility — USA
Flanders, New Jersey
Garonit’s global headquarters and primary manufacturing campus — the former Siemens Healthineers facility in Flanders, New Jersey — a 320,000+ square foot site spanning approximately 32 acres.
With a planned $200M investment over five years and the creation of up to 1,000 new jobs, Flanders dramatically expands Garonit’s finished dosage manufacturing capability and provides additional API production capacity — strengthening the U.S. supply chain at a national scale.
62 Bartly Road
Flanders, NJ 07836, USA
sales@garonitpharma.com
Secondary Facility — USA
Fairfield, New Jersey
Garonit’s dedicated Chlorhexidine Gluconate facility and secondary US manufacturing site. The Fairfield plant is purpose-built for CHG production — housed in a fully humidity-controlled environment that maintains optimal conditions year-round.
The plant is routinely inspected by the US FDA and maintains full cGMP compliance under 21 CFR Part 211. Global inventory is held at this facility, ensuring uninterrupted supply to North American and international customers at all times.
Manufacturing Facility — India
Garonit Pharmaceutical
India
Garonit Pharmaceutical Pvt. Ltd. is Garonit’s Indian manufacturing subsidiary, operating a WHO-GMP and ISO-certified facility in India. The plant serves Asia, CIS, LATAM, Africa, and Oceania — maintaining identical quality standards to the US facilities.
Garonit also operates Garonit Pharmaceutical UK Ltd, a commercial office in the United Kingdom that handles all European sales and distribution operations under the direction of Anna Klekner, UK & Europe Lead.
Quality Systems
One Standard. Every Site.
Whether your supply originates in New Jersey or India, every batch is manufactured, tested, and released under the same uncompromising quality framework.
Batch Release
Every batch undergoes full analytical testing before release, with complete batch documentation available to qualified buyers upon request.
In-Process Controls
Continuous in-process monitoring of critical quality attributes — concentration, pH, microbial load, and impurity profiles — at every stage of production.
Stability Programs
Ongoing ICH-aligned stability studies for all products. Data available for regulatory submissions in any target market.
Change Control
Formal change control procedures govern all process, equipment, and material changes. Customers are notified of any changes that may affect regulatory filings.
Deviation Management
All deviations, OOS results, and complaints are investigated through a root cause analysis system with CAPA documentation.
Supplier Qualification
All raw material suppliers are qualified against cGMP standards. Vendor audit program covers critical excipient and solvent suppliers.