GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Tranexamic Acid Sustained-Release Tablet 500mg
C) Tranexamic Acid Sustained-Release Tablet 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated, Sustained-Release tablet contain:
Tranexamic Acid IP ……………..............750mg
Excipients………………………………………..q.s.
Colour: Red Oxide of Iron
B) Tranexamic Acid Sustained-Release Tablet 500mg
Each Film-coated, Sustained-Release tablet contain:
Tranexamic Acid IP ……………..............500mg
Excipients………………………………………..q.s.
Colour: Yellow Oxide of Iron
C) Tranexamic Acid Sustained-Release Tablet IP 250mg
Each Film-coated, Sustained-Release tablet contain:
Tranexamic Acid IP ……………..............250mg
Excipients………………………………………..q.s.
Colour: Titanium Dioxide
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Dosage: As directed by the Physician
Tranexamic Acid Sustained Release Tablet 500mg Technical Specification:
| Product Name: | Tranexamic Acid Sustained Release Tablet |
| Brand Name: | Generic |
| Strength: | 250mg, 500mg, 750mg |
| Dosage Form: | Tablets (Un-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 150s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Gynaecological Product |
| Indication: | Tranexamic acid (sometimes shortened to txa) is a medicine that controls bleeding. It helps your blood to clot and is used for nosebleeds and heavy periods. If you’re having a tooth taken out, using tranexamic acid mouthwash can help stop bleeding |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Tranexamic Acid Sustained-Release Tablet 750mg
- Tranexamic Acid Sustained-Release Tablet 500mg
- Tranexamic Acid Sustained-Release Tablet 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Tranexamic Acid Sustained-Release Tablet 750mg
Each Film-coated, Sustained-Release tablet contain:
Tranexamic Acid IP ………………………..750mg
Excipients………………………………………..q.s.
Colour: Red Oxide of Iron - Tranexamic Acid Sustained-Release Tablet 500mg
Each Film-coated, Sustained-Release tablet contain:
Tranexamic Acid IP ………………………..500mg
Excipients………………………………………..q.s.
Colour: Yellow Oxide of Iron - Tranexamic Acid Sustained-Release Tablet IP 250mg
Each Film-coated, Sustained-Release tablet contain:
Tranexamic Acid IP ………………………..250mg
Excipients………………………………………..q.s.
Colour: Titanium Dioxide
THERAPEUTIC INDICATIONS:
- Tranexamic acid (sometimes shortened to txa) is a medicine that controls bleeding. It helps your blood to clot and is used for nosebleeds and heavy periods. If you’re having a tooth taken out, using tranexamic acid mouthwash can help stop bleeding.
CAUTION & SCHEDULE:
- CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH. - SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
- Storage: Store at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture.
- Dosage: As directed by the Physician
Introduction to Tranexamic Acid Sustained Release Tablet 500mg
Tranexamic Acid Sustained Release Tablet 500mg is a globally demanded anti-fibrinolytic medication widely used for preventing or treating excessive bleeding in multiple clinical conditions. As a hemostatic agent, it is particularly effective for:
-
Heavy menstrual bleeding (menorrhagia)
-
Post-operative bleeding
-
Bleeding after tooth extraction
-
Nosebleeds (epistaxis)
-
Dysfunctional uterine bleeding
-
Bleeding disorders related to oral, prostate, or bladder surgery
The sustained-release (SR) formulation ensures prolonged therapeutic action, reducing dosing frequency and maintaining stable plasma levels. This improves patient compliance, making it preferable for long-term treatment plans.
With a rising global demand for safe and effective bleeding-control medicines, Tranexamic Acid Sustained Release Tablet 500mg has become a key pharmaceutical formulation for hospitals, government tenders, NGOs, and private importers—especially in Asia, Africa, Latin America, and the Middle East.
Taj Pharma, the most reputed Tranexamic Acid Sustained Release Tablet 500mg Manufacturer in India, ensures unmatched purity, efficacy, safety, and compliance with global regulatory standards.
Leading Tranexamic Acid Sustained Release Tablet 500mg Manufacturer in India
Taj Pharma Ltd., headquartered in Vapi, Gujarat, is one of India’s most trusted manufacturers and exporters of Tranexamic Acid Sustained Release Tablet 500mg. Known for precision, quality, and high-volume production capacity, Taj Pharma supplies to hospitals, wholesalers, government procurement agencies, and international buyers across 40+ countries.
Medical Overview
This medication works by preventing the breakdown of blood clots, helping the body control bleeding more effectively. It is classified as an anti-fibrinolytic, acting by inhibiting plasminogen activation.
Clinical Uses
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Gynecological bleeding
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Surgical blood loss
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ENT bleeding
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Trauma-related bleeding episode management
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Menstrual disorders
Safety Information
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Common side effects: mild fatigue, muscle aches, joint pain
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Safe for pregnant and breastfeeding women (when prescribed)
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Safe for liver-impaired patients
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Avoid alcohol for better tolerance
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Not suitable for patients with a known allergy to Tranexamic Acid
Because of its excellent safety profile and therapeutic value, this formulation enjoys high global demand—making it essential for importers and distributors to source it from a reliable WHO-GMP-certified manufacturer like Taj Pharma.
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In-Depth Details for Importers, Exporters & Global Buyers
Regulatory Documentation Provided by Taj Pharma
Taj Pharma offers a complete regulatory support package required for international registrations:
-
WHO-GMP Certificate
-
COPP (Certificate of Pharmaceutical Product)
-
COA (Certificate of Analysis)
-
CTD/eCTD Dossier
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Stability Data (Accelerated & Real-time)
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Free Sale Certificate
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MSDS (Material Safety Data Sheet)
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Batch Manufacturing Records
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Procedure & Protocol Compliance Certificates
This makes regulatory filings smooth and fast for importers across Africa, Southeast Asia, LATAM, CIS, and GCC nations.
Custom Packaging & Labeling
Taj Pharma supports country-specific packaging guidelines, providing:
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Alu-Alu blister packs
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PVC/PVDC blister packs
-
Hospital bulk packs
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Bottles (HDPE/Pharma grade)
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Cold chain support (if required)
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Multilingual labeling (English + local languages)
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Custom brand name printing
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Neutral or tender-specific packaging
This ensures compliance with local drug regulations, improving acceptance in government tenders and private markets.
Shelf-Life, Storage & Dosage Form
-
Shelf-life: 24–36 months
-
Storage: Keep below 25°C; protect from moisture
-
Dosage Form: Sustained Release Tablet
-
Strength: 500mg
Export Certifications Available
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WHO-GMP
-
ISO 9001:2015
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GLP
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COPP (for selected countries)
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FSC (Free Sale Certificate)
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GMP Clearance for exports
-
Certificate of Origin
-
Country-Specific MOH Approvals
Target Countries & Export Markets
Taj Pharma exports Tranexamic Acid Sustained Release Tablet 500mg to 40+ global markets.
Top 20 Export Countries
ia | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile
Taj Pharma is also expanding its footprint in Europe, South America, and Eastern Europe due to rising regulatory approvals.
Why Taj Pharma Is the Most Trusted Global Manufacturer & Supplier
1. State-of-the-Art WHO-GMP Manufacturing Facilities
Taj Pharma operates ultra-modern plants equipped with:
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Automated production lines
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Advanced granulation & compression systems
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Class 100,000 cleanrooms
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European-grade blister packaging machines
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In-house microbiology & QC labs
2. Affordable Pricing with Guaranteed Quality
As a high-volume manufacturer, Taj Pharma ensures economical pricing without compromising on global quality standards.
3. Comprehensive Global Supply Chain
The company ensures:
-
Fast turnaround time
-
Ready stocks
-
Reliable port handling
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Shipping from Mundra / Nhava Sheva
4. Global Presence & Partnerships
Taj Pharma supplies to:
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Hospitals
-
Ministries of Health
-
NGOs
-
Private distributors
-
Government tenders
-
PCD Franchise networks
Technical Product Specification Table
| Parameter | Specification |
|---|---|
| Product Name | Tranexamic Acid Sustained Release Tablet |
| Strength | 500mg |
| Form | Sustained Release Film-Coated Tablet |
| Manufacturer | Taj Pharma Ltd., Vapi, Gujarat, India |
| Therapeutic Class | Anti-fibrinolytic / Hemostatic |
| Packaging Type | Alu-Alu Blister / Custom Packs |
| API Purity | ≥ 99% |
| Pharmacopoeia Standards | IP / BP / USP |
| Shelf-Life | 24–36 months |
| Regulatory Approval | WHO-GMP, ISO, COPP |
| Minimum Order Quantity | 100,000 Tablets |
| Export Formulation | CTD/eCTD compliant |
| Storage Conditions | Below 25°C, moisture-free |
Call to Action for Buyers & Distributors
If you are looking for a trusted Tranexamic Acid Sustained Release Tablet 500mg Manufacturer in India, then Taj Pharma is your most reliable partner for export, wholesale, and PCD franchise supply.
📩 Contact Taj Pharma Today
Email: info@tajpharma.com
Website: www.tajpharma.com
Head Office: Vapi, Gujarat, India
Taj Pharma assures global buyers of world-class quality, compliance, and a seamless export experience.
Top 20 FAQs
1. What is Tranexamic Acid SR Tablet 500mg used for?
To prevent or reduce excessive bleeding in various medical conditions.
2. Is Taj Pharma a WHO-GMP-certified manufacturer?
Yes. Taj Pharma is globally recognized for WHO-GMP production.
3. Do you offer customized packaging?
Yes, including multilingual and country-specific packaging.
4. What is the minimum export order?
Minimum 100,000 tablets.
5. Do you provide CTD dossier?
Yes, full CTD/eCTD dossiers are available.
6. Which countries do you export to?
Over 40 markets in Africa, Asia, Middle East, and Latin America.
7. Is the medication safe for pregnant women?
Yes, when medically advised.
8. What side effects should I expect?
Mild fatigue, muscle or joint pain.
9. Do you supply PCD Pharma Franchise?
Yes, across PAN India.
10. Is the sustained-release version more effective?
Yes, due to better compliance and stable plasma levels.
11. Can you handle government tender supplies?
Yes, Taj Pharma regularly supplies to global tenders.
12. Do you offer third-party manufacturing?
Yes, OEM/contract manufacturing is available.
13. What is the typical lead time?
7–12 working days.
14. Are bulk packs available?
Yes, for hospitals and tenders.
15. Do you provide Free Sale Certificates?
Yes.
16. Can labeling be customized?
Absolutely.
17. What port do you use for shipping?
Nhava Sheva or Mundra.
18. Is the product IP/BP/USP compliant?
Yes.
19. Do you test each batch?
Every batch undergoes strict QC/QA testing.
20. Why choose Taj Pharma?
For global quality, affordability, and dependable export support.






