Export region
Tablet coating material exported to North America
US FDA oversight, USP-NF specifications and Drug Master File referencing.
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
- Compliance
- WHO-GMP Compliance Unit
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
What matters most in North America.
- AQ-ZWt10Aqueous film coat, extra whiteWater base extra white film coat for cores that show through a standard white.Film coating
- ECM-RP347Enteric coat, methacrylic base, non-aqueousSolvent base methacrylic enteric film for the Pantoprazole group.Enteric coating
- MB 31RPMoisture barrier for multivitamin and ferrous tabletsSolvent base barrier film for hygroscopic multivitamin and iron formulations.Moisture barrier
What ships to North 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