Export region

Tablet coating material exported to North America

US FDA oversight, USP-NF specifications and Drug Master File referencing.

Written by the Rglax Pharma technical team, who formulate and manufacture every grade named on this page at our WHO-GMP works in Tahliwal, Una (drug manufacturing licence NNZ/23/238). Reviewed 3 September 2026. Licences and certificates.

Send an export enquiry +91 98821 30484

A colour fan deck beside coated tablets — The markets we supply across North America, and the route from Tahliwal. Not a statement of registration in any market.

What this region runs

We supply into the United States, and US and Canadian oral solid manufacture works to USP-NF excipient monographs. Finished product applications commonly reference a Drug Master File for a coating system rather than restating the formulation, which is why the DMF question comes up early here and rarely anywhere else.

Why our range fits it

Our U.S.-DMF is applied for rather than granted, and we will not describe it as anything else. If you are evaluating us for a North American application, that is the first thing to establish, and we would rather you know it before you spend time on a technical evaluation.

What to send us

Tell us the application stage you are at and whether DMF reference is a requirement for your submission. We will give you the current status in writing.

Market facts

Markets: United States, Canada
Pharmacopoeia: USP-NF, with excipient monographs in the National Formulary.
Exported from: Plot No. 30, Industrial Area Tahliwal, Himachal Pradesh, India
Licence: NNZ/23/238
Compliance: WHO-GMP Compliance Unit
DMF: U.S.-DMF applied

Regulators you would be working under

US FDA
Health Canada

Listed so you know the framework we would be supplying into. It is not a claim that we hold a registration or approval with any of them.

Grades

The 3 grades most asked for in North America.

Chosen against the climate zone, the product mix and the documentation expectations of the region. Each links to its full page, with the process parameters it was developed on.

AQ-ZWt10 Film coating
Aqueous film coat, extra white
Water base extra white film coat for cores that show through a standard white.
Aqueous extra white film coat developed for tablets where the core colour bleeds through a conventional white film. Calcium and Azithromycin cores are the usual cases. It gives higher opacity at the same build-up.
Base ·
Aqueous
Finish ·
Extra white, high opacity
Formulated against ·
Calcium, Azithromycin
ECM-RP347 Enteric coating
Enteric coat, methacrylic base, non-aqueous
Solvent base methacrylic enteric film for the Pantoprazole group.
Methacrylic base enteric coating applied from a non-aqueous system, formulated for the Pantoprazole group and other dissolution critical enteric tablets. It runs best over a transparent seal coat such as SC-401, which protects the acid labile core.
Base ·
Non-aqueous (solvent)
Finish ·
Enteric film, gastro resistant
Formulated against ·
Pantoprazole group
MB 31RP Moisture barrier
Moisture barrier for multivitamin and ferrous tablets
Solvent base barrier film for hygroscopic multivitamin and iron formulations.
Solvent base moisture barrier film coat for Multivitamin and Ferrous group tablets. It protects the core from moisture pick-up and from the colour change that follows it on shelf.
Base ·
Non-aqueous (solvent)
Finish ·
Colour or white, moisture barrier
Formulated against ·
Multivitamins, Ferrous group