Anti-tuberculosis · Four-drug combination
Rifampicin, isoniazid, pyrazinamide and ethambutol fixed-dose tablets
The standard first-line tuberculosis treatment in a single tablet, taken in the first two months. Progene Pharma supplies rifampicin, isoniazid, pyrazinamide and ethambutol as a four-drug fixed-dose tablet, packed by weight band for programmes and tenders, under your brand and with the documents you need to register it.
- Forms
- Tablets
- Strengths
- 1 options
- Supply
- Private label or ready brand
- Documents
- COA, COPP, MSDS, dossier
Available strengths
Rifampicin / isoniazid / pyrazinamide / ethambutol in each tablet. Other strengths, weight-band kits, and programme and tender packs are made to order. Pack sizes and labelling are made to match your registration.
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150 / 75 / 400 / 275 mg
Tablet
Rifampicin / isoniazid / pyrazinamide / ethambutol, packed by weight band
About rifampicin, isoniazid, pyrazinamide and ethambutol
What it treats
This four-drug combination treats drug-susceptible tuberculosis (TB) and is the standard treatment for the first two months of a six-month regimen, called the intensive phase. After that, patients continue with rifampicin and isoniazid for four more months. The World Health Organization recommends fixed-dose combinations, and the individual medicines are on its Model List of Essential Medicines.
Why one tablet
Four medicines in one tablet cut the number of pills a patient takes each day, make it harder to take only some of the medicines, and simplify buying, storage and distribution for national programmes. Doses are matched to body weight bands, so patients take a set number of tablets for their weight.
How it is taken
The tablets are taken once a day, usually on an empty stomach, under the supervision of a clinic or programme. The side effects of all four medicines apply, including a harmless orange-red colour in urine, possible effects on the liver, nerves and eyesight, and joint pain. Tuberculosis treatment lasts at least six months and must be completed under a clinician or programme, so patients should always follow the approved label and the national guidelines in their country.
Prescription medicine. This information is for distributors and healthcare professionals and is not medical advice.
Made for your market
Registration rules differ from country to country. We build the product around yours.
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Private label
Your brand name on the carton, blister foil and leaflet, designed to your regulator's rules.
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Packaging
Pack sizes, languages and artwork to suit how the medicine is prescribed and sold in your country.
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Registration documents
COPP, MSDS and the product dossier for registration, and a COA with every batch.
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Certified manufacturing
Manufactured in a facility certified to WHO-GMP, EU-GMP and ISO. What each standard means
How ordering works
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01
Tell us what you need
The strength, pack size, quantity and the country you are registering in.
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02
Quotation and documents
We confirm price, lead time and the certification and paperwork your regulator expects.
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03
Manufacture and testing
Manufactured in a certified facility. Every batch is tested and released with a COA.
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04
Shipping
Packed for export and shipped with the documents you need for import clearance.
Other tuberculosis medicines we supply
Ask for any of these with your quotation, or see the full product list.
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Capsules 150, 300, 450 and 600 mg
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Tablets 100 and 300 mg
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Tablets 400 and 800 mg
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Tablets 500 mg
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Fixed-dose combination tablets
Questions about rifampicin, isoniazid, pyrazinamide and ethambutol
Something else? Email [email protected].
Which strengths of the four-drug tablet do you supply?
Tablets of 150 mg / 75 mg / 400 mg / 275 mg, packed by weight band. Other strengths and kit presentations can be made to order, and pack sizes and labelling are made to match the registration in your country.
Do you make patient kits by weight band?
Yes. Doses can be packed for the full course by weight band, in the layout your programme uses. Tell us the specification and we will confirm what we can supply.
Is there a paediatric version?
For young children, programmes often use a three-drug dispersible tablet of rifampicin, isoniazid and pyrazinamide, with ethambutol added separately where the guidelines direct. Tell us the combination your programme uses and we will confirm what we can supply.
Can you supply it under our own brand?
Yes. Progene Pharma manufactures it as a private label product, with the carton, blister foil or label and patient leaflet designed for your market and your regulator's requirements.
Which documents come with it?
Every batch ships with a Certificate of Analysis (COA). Progene Pharma also provides the Certificate of Pharmaceutical Product (COPP), MSDS and the product dossier you need to register and import it.
Where is it manufactured?
Progene Pharma manufactures it in a WHO-GMP certified facility in India, also certified to EU-GMP and ISO standards. Tell us your destination country and we will confirm which certification applies to your order.
What is the minimum order quantity and lead time?
Both depend on the strength, pack size and documents your market needs. We confirm them with your quotation, and we work with large importers as well as smaller distributors.
Related pages
- Anti-tuberculosis
- Rifampicin
- Isoniazid
- Ethambutol
- Pyrazinamide
- Private label rifampicin, isoniazid, pyrazinamide and ethambutol
- Export documentation
- Rifampicin, isoniazid, pyrazinamide and ethambutol export to Africa
- Rifampicin, isoniazid, pyrazinamide and ethambutol export to Latin America
- Rifampicin, isoniazid, pyrazinamide and ethambutol export to Southeast Asia
- Markets we supply
Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494