Export: +91 9820402906   Domestic: +91 7710003340 | HR: +91 9137757219
Rifaximin Tablets – Manufacturer & Exporter India

Rifaximin Tablets – Manufacturer & Exporter India

Product Composition

Each film-coated tablet contains: Rifaximin (In-house specification) 400 mg.

Therapeutic category: Gastrointestinal antibiotic (rifamycin derivative)

Category: Antibiotic drugs

Manufacturer: Healthy Life Pharma Pvt. Ltd. (certification subject to verification)

Exporter: Healthy Inc (export credentials subject to verification)

SKU: Rifaximin Tablets 400 mg

+91 7710003340

Product Information

Rifaximin Tablets – Manufacturer & Exporter India is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

Categories: Pharmaceutical Exporter India · Pharmaceutical Formulations India · WHO GMP Certified Formulations

1. Product Introduction

Rifaximin is a minimally absorbed rifamycin-class antibiotic that acts predominantly in the gastrointestinal tract. Depending on country-specific approval and tablet strength, rifaximin products may be used to reduce recurrence of overt hepatic encephalopathy, treat certain forms of traveller’s diarrhoea caused by non-invasive E. coli, or manage irritable bowel syndrome with diarrhoea (IBS-D). Indications are not interchangeable across strengths or jurisdictions.

Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter in the supplied product information. Facility certifications and market authorisations should be checked against current documents.

2. Product Specifications

ProductRifaximin Tablets
Active ingredientRifaximin 400 mg per film-coated tablet
SpecificationIn-house (as supplied)
CAS80621-81-4
Dosage formFilm-coated tablet
Therapeutic classGastrointestinal antibiotic / rifamycin derivative
Packaging and shelf lifeTo be confirmed from approved product label and stability dossier
Other strengths200 mg and 550 mg mentioned in source description; not confirmed by supplied composition

3. Manufacturing and Formulation Considerations

Rifaximin polymorphism can influence its physicochemical characteristics. An appropriate formulation strategy includes qualified API sourcing, control of solid-state form where relevant, validated blending and coating, and moisture-protective packaging supported by stability data. Specific use of alpha-polymorph controls, X-ray diffraction, micronisation or direct compression must be substantiated by actual manufacturing records before being claimed.

4. Quality Assurance

Release testing should follow the approved in-house specification and market registration, including identity, assay, related substances, dissolution, uniformity, microbiological quality where applicable, and stability. Analytical methods and acceptance limits must be drawn from validated methods and the approved dossier rather than generic numeric claims. Where solid-state form is critical, appropriate analytical characterization may be needed.

5. Mechanism and Therapeutic Uses

Rifaximin inhibits bacterial DNA-dependent RNA polymerase, reducing susceptible intestinal bacterial activity. In hepatic encephalopathy it is used in certain approved settings to reduce the risk of recurrent overt episodes, often alongside other treatment such as lactulose. Other indications, including non-invasive E. coli traveller’s diarrhoea and IBS-D, depend on the jurisdiction and approved formulation. Rifaximin is not appropriate for invasive diarrhoeal illness with fever or blood in stools.

6. Export and Regulatory Support

For B2B enquiries, request current manufacturing licence, GMP evidence, product-specific registration status, certificate of analysis, approved artwork, stability information, and any CTD/ACTD dossier that is actually available. Shipment terms and destination-market eligibility require commercial and regulatory confirmation.

7. Frequently Asked Questions

What is the confirmed strength?

The provided composition confirms Rifaximin 400 mg per film-coated tablet.

Is 400 mg approved for hepatic encephalopathy everywhere?

No. Approved strengths and dosing schedules vary by country. The commonly cited 550 mg twice-daily regimen is not a dosing instruction for this 400 mg product.

Does minimal absorption mean there are no systemic risks?

No. Systemic exposure can increase in severe liver impairment and with certain interacting medicines, including cyclosporine.

Can rifaximin treat urinary tract infections?

It is not a standard treatment for urinary tract infections because its action is predominantly within the gut.

8. Dosage and Administration

Use only according to the approved prescribing information for the particular 400 mg formulation, diagnosis, patient condition and destination market. Do not substitute a 400 mg tablet into a 200 mg or 550 mg regimen without clinician and regulatory confirmation. Administration with or without food may be allowed under some labels; follow the product-specific instructions.

9. Side Effects and Precautions

Possible adverse effects include nausea, abdominal discomfort, headache, dizziness and peripheral oedema in some treated populations. Serious concerns include hypersensitivity reactions and Clostridioides difficile-associated diarrhoea. Use caution in severe hepatic impairment and with P-glycoprotein inhibitors such as cyclosporine. Antimicrobial resistance can occur; rifaximin should not be described as resistance-free. Patients with bloody diarrhoea or fever require medical assessment rather than routine rifaximin self-treatment.

10. Storage Instructions

Store according to the approved product label, protected from excessive moisture and environmental exposure. A fixed storage temperature or 36-month shelf life should not be published without approved stability documentation.

Professional product information only. Product approvals, certifications, strengths, indications and specifications must be confirmed for each market. Not a substitute for prescribing information or medical advice.