GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg
B) Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg
Each uncoated tablet contains:
Trimethoprim USP…………………….80mg
Sulfamethoxazole USP……………….400mg
Excipients………………………………..q.s.
Colours: Quinizarine green ss


B) Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg
Each uncoated tablet contains:
Trimethoprim USP…………………….160mg
Sulfamethoxazole USP……………….800mg
Excipients………………………………..q.s.
Colours: Red oxide of iron

THERAPEUTIC INDICATIONS:

Sulfamethoxazole + Trimethoprim is used in the treatment of bacterial infections. It is used to treat bacterial infections such as pneumonia, bronchitis, infections of urinary tract, ear and intestines.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg   Technical Specification:

Product Name: Trimethoprim and Sulfamethoxazole Tablets USP
Brand Name: Generic
Strength: 80mg+400mg, 160mg+800mg
Dosage Form: Tablets (Uncoated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Antibacterials, Antibiotic
Indication: Trimethoprim and Sulfamethoxazole is a combination antibiotic used to treat ear infections, urinary tract infections, bronchitis, traveler’s diarrhea, shigellosis, and Pneumocystis.
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg
B) Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Trimethoprim and Sulfamethoxazole Tablets USP 80mg+400mg
Each uncoated tablet contains:
Trimethoprim USP…………………….80mg
Sulfamethoxazole USP……………….400mg
Excipients………………………………..q.s.
Colours: Quinizarine green ss

B) Trimethoprim and Sulfamethoxazole Tablets USP 160mg+800mg
Each uncoated tablet contains:
Trimethoprim USP…………………….160mg
Sulfamethoxazole USP……………….800mg
Excipients………………………………..q.s.
Colours: Red oxide of iron

THERAPEUTIC INDICATIONS:

Sulfamethoxazole + Trimethoprim is used in the treatment of bacterial infections. It is used to treat bacterial infections such as pneumonia, bronchitis, infections of urinary tract, ear and intestines.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician.

Attach dispensing label as per end country.

Introduction to Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg

Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg is a widely prescribed antibiotic combination medicine used globally for the treatment of multiple bacterial infections. This formulation combines two powerful antibiotics – Trimethoprim (80mg) and Sulfamethoxazole (400mg) – that work synergistically to prevent bacteria from producing folic acid, a nutrient essential for their growth and multiplication.

These tablets are extensively used to treat infections such as:

  • Pneumonia

  • Bronchitis

  • Urinary tract infections (UTIs)

  • Ear infections

  • Intestinal infections

The demand for Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg is increasing across Asia, Africa, Latin America, the Middle East, and CIS countries due to rising cases of bacterial infections and the need for affordable, broad-spectrum antibiotic therapies.


In-Depth Details for Importers, Exporters & Global Buyers

When sourcing Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg from India, global buyers seek a reliable manufacturer that offers complete regulatory support, consistent quality, and efficient supply chain solutions.

✅ Regulatory Documentation Provided

Taj Pharma provides all essential export and registration documentation including:

  • WHO-GMP, EU-GMP certifications

  • Certificate of Pharmaceutical Product (CoPP)

  • CTD/eCTD Dossiers

  • Stability studies (Zone III & IV)

  • Free Sale Certificates

✅ Custom Packaging & Labeling

  • Export-grade blister packs & bottles

  • Multilingual labeling as per country-specific regulatory needs

  • Bulk packing & hospital supply packs

✅ Shelf-life, Storage & Dosage Form

  • Dosage form: Oral tablet

  • Shelf-life: 24–36 months (depending on packaging)

  • Storage: Store below 30°C in a dry place away from sunlight

✅ Export Certifications

Taj Pharma holds international certifications ensuring compliance with strict regulatory guidelines:

  • WHO-GMP

  • EU-GMP (select facilities)

  • ISO 9001:2015

  • MHRA, PIC/S, and other regulatory approvals

✅ Target Export Markets

Taj Pharma exports Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg to:

  • African countries (Nigeria, Kenya, South Africa, Ghana, Tanzania)

  • Middle East (UAE, Saudi Arabia, Iraq, Yemen)

  • CIS countries (Russia, Ukraine, Kazakhstan, Uzbekistan)

  • Asia (Vietnam, Myanmar, Cambodia, Philippines)

  • Latin America (Peru, Ecuador, Bolivia, Brazil)


Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

🌐 State-of-the-Art Manufacturing

Taj Pharma operates WHO-GMP certified facilities in Vapi, Gujarat, India, equipped with advanced technology, automated quality control systems, and robust R&D infrastructure.

💲 Affordable Pricing with Assured Quality

As a leading Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg manufacturer in India, Taj Pharma ensures global accessibility by offering cost-effective pricing without compromising on international quality benchmarks.

🚚 Global Presence & Supply Chain Support

Taj Pharma maintains a strong global distribution network with timely shipping to over 40+ countries, supported by strategic alliances with importers, distributors, and government procurement agencies.

🌍 Top 20 Export Countries for Taj Pharma

  1. Nigeria

  2. Kenya

  3. South Africa

  4. Ghana

  5. Tanzania

  6. Ethiopia

  7. UAE

  8. Saudi Arabia

  9. Iraq

  10. Yemen

  11. Vietnam

  12. Philippines

  13. Myanmar

  14. Cambodia

  15. Russia

  16. Ukraine

  17. Peru

  18. Ecuador

  19. Bolivia

  20. Brazil


Technical Product Specification Table

Parameter Details
Product Name Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg
Manufacturer Taj Pharma Ltd., Vapi, Gujarat, India
Active Ingredients Trimethoprim 80mg + Sulfamethoxazole 400mg
Dosage Form Oral tablet
Packaging Blister packs / Bottles / Bulk packs
Shelf Life 24–36 months
Certifications WHO-GMP, EU-GMP, ISO, CoPP
Storage Conditions Below 30°C, dry place, protect from light
Indications Pneumonia, Bronchitis, UTIs, Ear & Intestinal Infections
Common Side Effects Nausea, Vomiting, Rash, Headache, Diarrhea

Call to Action

If you are a global distributor, importer, government agency, or PCD franchise owner searching for a trusted Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg manufacturer in India, Taj Pharma is your best partner.

📞 Contact Taj Pharma today to request samples, quotations, or regulatory documents.


Top 20 FAQs on Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg

Q1: What is Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg used for?
A1: It treats bacterial infections like pneumonia, bronchitis, UTIs, ear, and intestinal infections.

Q2: Who manufactures Trimethoprim and Sulfamethoxazole Tablets 80mg+400mg in India?
A2: Taj Pharma is a WHO-GMP-certified manufacturer, supplier, and exporter from Vapi, Gujarat, India.

Q3: What certifications does Taj Pharma hold?
A3: WHO-GMP, EU-GMP, ISO 9001:2015, and CoPP for global registrations.

Q4: Can these tablets be exported worldwide?
A4: Yes, Taj Pharma exports to over 40+ countries.

Q5: What is the shelf life?
A5: 24–36 months depending on packaging.

Q6: Does Taj Pharma provide CTD/eCTD dossiers?
A6: Yes, complete regulatory documentation is available.

Q7: Are customized labels available?
A7: Yes, multilingual labels can be provided as per importer requirements.

Q8: What is the recommended dosage?
A8: Typically one tablet twice daily (as prescribed by a physician).

Q9: Are there side effects?
A9: Possible nausea, vomiting, rash, diarrhea, and headache.

Q10: Is it safe during pregnancy?
A10: Not recommended unless prescribed by a doctor.

Q11: Can Taj Pharma provide samples for registration?
A11: Yes, samples are available for regulatory filing.

Q12: What packaging types are available?
A12: Blister packs, bottles, and hospital bulk packs.

Q13: Does Taj Pharma offer third-party manufacturing?
A13: Yes, contract manufacturing is available.

Q14: Are these tablets available at the best price in Mumbai, India?
A14: Yes, Taj Pharma ensures competitive pricing PAN India.

Q15: Which regions have the highest demand?
A15: Africa, Asia-Pacific, CIS, and Middle East.

Q16: What is the mode of shipment?
A16: By air and sea freight with temperature-controlled logistics.

Q17: Can distributors get monopoly rights?
A17: Yes, through Taj Pharma’s PCD Pharma Franchise model.

Q18: Are dossiers available in CTD format?
A18: Yes, both CTD and ACTD formats are available.

Q19: Can government tenders be supplied?
A19: Yes, Taj Pharma actively supplies to government tenders worldwide.

Q20: Why choose Taj Pharma over other manufacturers?
A20: Due to quality, affordability, certifications, global reach, and reliability.