Progene Pharma

Anti-tuberculosis · Fixed-dose combination

Rifampicin and isoniazid fixed-dose tablets

A two-drug fixed-dose tablet for the continuation phase of tuberculosis treatment, taken after the first two months. Progene Pharma supplies rifampicin and isoniazid in adult and paediatric strengths, packed by weight band for programmes and tenders, under your brand and with the documents you need to register it.

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Forms
Tablets
Strengths
2 options
Supply
Private label or ready brand
Documents
COA, COPP, MSDS, dossier

Available strengths

Rifampicin / isoniazid in each tablet. Other strengths, and programme and tender packs, are made to order. Pack sizes and labelling are made to match your registration.

  • 150 / 75 mg

    Tablet

    For adults and older children

  • 75 / 50 mg

    Dispersible tablet

    For young children, dissolves in water

About rifampicin and isoniazid

What it treats

Rifampicin and isoniazid is a fixed-dose combination used to treat drug-susceptible tuberculosis (TB). It is the standard treatment for the continuation phase, the last four months of a six-month regimen, after the first two months of four-drug treatment. Both medicines are on the World Health Organization Model List of Essential Medicines.

Why a fixed-dose tablet

Taking two medicines in one tablet means fewer pills each day, which helps patients keep to a long course, and it prevents the mistake of taking only one of the two medicines, which would encourage resistance. Programmes buy it in weight-band packs so that each patient receives the right dose.

How it is taken

The tablets are taken once a day, usually on an empty stomach, with the number of tablets set by body weight. The side effects of both medicines apply, including a harmless orange-red colour in urine and possible effects on the liver and nerves. 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.

  • Private label

    Your brand name on the carton, blister foil and leaflet, designed to your regulator's rules.

  • Packaging

    Pack sizes, languages and artwork to suit how the medicine is prescribed and sold in your country.

  • Registration documents

    COPP, MSDS and the product dossier for registration, and a COA with every batch.

  • Certified manufacturing

    Manufactured in a facility certified to WHO-GMP, EU-GMP and ISO. What each standard means

How ordering works

  1. 01

    Tell us what you need

    The strength, pack size, quantity and the country you are registering in.

  2. 02

    Quotation and documents

    We confirm price, lead time and the certification and paperwork your regulator expects.

  3. 03

    Manufacture and testing

    Manufactured in a certified facility. Every batch is tested and released with a COA.

  4. 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.

Questions about rifampicin and isoniazid

Something else? Email [email protected].

Which strengths of rifampicin and isoniazid do you supply?

Tablets of 150 mg / 75 mg for adults and older children, and 75 mg / 50 mg dispersible tablets for young children. Other strengths and weight-band packs can be made to order, and pack sizes and labelling are made to match the registration in your country.

Is it used for the first two months of treatment?

No. The first two months use four medicines, rifampicin, isoniazid, pyrazinamide and ethambutol, often in a four-drug tablet. This two-drug tablet is for the remaining months of treatment.

Do you make paediatric packs?

Yes. The 75 mg / 50 mg dispersible tablet is made for young children, and we pack each weight band in the course length your guidelines use.

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.

Request a quote

Send us your product requirements and target country. Our team will reply with a quotation and next steps.

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Email
[email protected]
Phone
+91 22 49793146
WhatsApp
+91 90829 70494
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