Export region
Tablet coating material exported to Latin America
Strong national regulators with detailed dossier requirements and established generic industries.
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.

What this region runs
Brazil and Mexico both carry large domestic generic industries with demanding national dossier requirements. ANVISA in particular expects excipient documentation in depth, and the registration timeline reflects that.
Why our range fits it
This is the region where documentation, rather than formulation, is most often the deciding factor. It is worth establishing early exactly what your regulatory affairs team needs from an excipient supplier, because the answer here is more detailed than in most markets we serve.
What to send us
Start with your documentation list rather than the technical requirement. We would rather tell you at the outset what we can and cannot supply for an ANVISA or COFEPRIS submission than find out at dossier stage.
Market facts
- Markets
- Brazil, Mexico, Colombia, Peru, Chile, Argentina
- Pharmacopoeia
- USP predominantly, with the Brazilian Pharmacopoeia applying in Brazil.
- 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
- ANVISA, Brazil
- COFEPRIS, Mexico
- INVIMA, Colombia
- DIGEMID, Peru
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 4 grades most asked for in Latin 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.
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
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
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
Sustained release material
Ready-mix blend for extended release solid dosage forms.
Sustained release material for controlled release drug delivery systems. It is supplied as a ready-mix so the release profile is reproducible batch to batch without in-house polymer blending.
- Base ·
- Dry blend
- Finish ·
- Functional release layer
What ships to Latin America
Tablets coated on our own pan at Tahliwal. Shade is matched against a retained sample you send us, not against a colour code.

Metallic blue DB3012

Aqueous colour film coat

Extra white film coat

Pearl and metallic finish
Read next
- Enteric Coating SystemDelayed release polymers on methacrylic, phthalate and CAP bases for aqueous or organic processing.
- Film Coating SystemAqueous and non-aqueous film coats, formulated to your application and regulatory requirement.
- Moisture Barrier CoatingHPMC and PVA based immediate release systems that protect against light, moisture and environmental gases.
- Sustained Release SystemControlled release drug delivery blends for extended release solid dosage forms.
- How an export order runsEnquiry, trial quantity, documentation and despatch, in the order they happen.
- Technical documentsWhat a TDS, MSDS, CoA and regulatory pack each contain, and which travel with a consignment.
- Licences and certificatesThe drug manufacturing licence, GMP compliance and registrations an importing authority will ask about.




