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Rglax Pharma

Export region

Tablet coating material exported to Latin America

Strong national regulators with detailed dossier requirements and established generic industries.

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
Compliance
WHO-GMP Compliance Unit

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.

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 coated tablets beside an Rglax DB3012 coating dispersion

    Metallic blue DB3012

  • Orange film coated caplets with a break line

    Aqueous colour film coat

  • White film coated round tablets

    Extra white film coat

  • Metallic blue round coated tablets

    Pearl and metallic finish

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