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Rglax Pharma

Export region

Tablet coating material exported to Africa

High volume generic manufacture across a spread of national regulators, most of which lean on WHO-GMP.

What this region runs

The continent runs a large share of Africa’s own generic manufacture alongside imported finished product. Anti infectives, antimalarials, analgesics and multivitamins dominate the oral solid mix, and several national regulators accept a WHO-GMP assessment as the basis for a supplier.

Why our range fits it

Most of the region sits in ICH stability Zone IVb, hot and very humid. That single fact drives more coating decisions here than anything else, because a film that holds in a temperate warehouse can fail a Zone IVb stability pull. Our moisture barrier grades exist for exactly this problem, and the enteric grades are formulated to keep their integrity through the same conditions.

What to send us

Send the tablet, the target shelf life and the stability zone you are testing to. If you have a failed stability pull, send the data with it, because the failure tells us more about which grade you need than the specification does.

Market facts

Markets
Nigeria, Kenya, Ghana, Tanzania, Uganda, Ethiopia, South Africa
Pharmacopoeia
British Pharmacopoeia and USP are both in common use, with WHO guidance underneath.
Exported from
Plot No. 30, Industrial Area Tahliwal, Himachal Pradesh, India
Compliance
WHO-GMP Compliance Unit

Regulators you would be working under

  • NAFDAC, Nigeria
  • PPB, Kenya
  • FDA, Ghana
  • TMDA, Tanzania
  • SAHPRA, South Africa

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 Africa

Tablets coated on our own pan at Tahliwal. Shade is matched against a retained sample you send us, not against a colour code.

  • Metallic gold non-aqueous film coated caplets

    Metallic gold film coat

  • 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

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