Film-Coated Tablet | Antifibrinolytic / Hemostatic Medicine
Each film-coated tablet contains: Tranexamic Acid BP 500 mg; excipients q.s. Titanium dioxide is mentioned in the supplied formula; its presence and regulatory acceptability must be checked against the approved composition.
Usage: Treatment of heavy menstrual bleeding where clinically appropriate and authorized.
Therapeutic category: Antifibrinolytic / Hemostatic agent (not an antiplatelet or antihypertensive).
SKU: Tranexamic Acid Tablets BP 500 mg
Categories: Contract Manufacturer · Manufacturing Pharmaceutical Company India · Pharmaceutical Exporter India · Pharmaceutical Formulations India · Formulations Exporter India · Tablets Manufacturer · WHO GMP Certified Formulations
Tranexamic Acid Tablets BP 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.
Tranexamic acid is an antifibrinolytic medicine that helps reduce excessive bleeding by slowing the breakdown of formed blood clots. The supplied product label confirms a 500 mg BP film-coated tablet, primarily presented for heavy menstrual bleeding (HMB).
Healthy Life Pharma Pvt. Ltd. is identified in the supplied company description as manufacturer and Healthy Inc as exporter. Contract manufacturing, WHO-GMP certification, site details and export authorizations should be confirmed from current supporting documents before publication as verified facts.
| Product name | Tranexamic Acid Tablets |
|---|---|
| Active ingredient | Tranexamic Acid BP 500 mg per tablet |
| Confirmed strength | 500 mg |
| Dosage form | Film-coated oral tablet |
| Pharmacopoeial reference | BP, per supplied label |
| Therapeutic class | Antifibrinolytic / Hemostatic agent |
| Additional ingredient | Titanium dioxide listed; confirm final approved excipient formula and local regulatory requirements |
| Other strengths | 250 mg mentioned in background; not confirmed by supplied product label |
| Packaging and shelf life | Subject to approved packaging specification and stability data |
Manufacture of a film-coated tranexamic acid tablet involves qualified raw materials, validated blending/granulation or direct compression, compression, and a suitable film-coating process. Formulation design should demonstrate uniformity, adequate mechanical strength, and consistent release under the registered specifications.
Specific disintegrants, coating materials, manufacturing equipment, facility certification, and performance claims require confirmation from the approved master formula, batch records and validation documents. A claim of rapid emergency bleeding control should not be inferred from oral tablet disintegration alone.
Quality control should cover identification, assay, related substances, dosage-unit uniformity, dissolution/disintegration as applicable, microbiological quality where required, packaging integrity and stability, in accordance with the registered BP-based specification.
Numerical claims such as “more than 85% release in 15 minutes” cannot be verified from the supplied label and should not be used without approved analytical methods and batch results.
Tranexamic acid inhibits fibrinolysis by interfering with plasminogen activation and plasmin interaction with fibrin. It helps stabilize existing clots and reduce blood loss; it does not function as an antiplatelet medicine.
Heavy menstrual bleeding is a recognized use for oral tranexamic acid, subject to local approval and clinician assessment. Tranexamic acid is also used in selected surgical and other bleeding settings, but route, formulation, dosing and authorization differ by indication. Postpartum hemorrhage requires urgent hospital management, where intravenous tranexamic acid may be used under established protocols; oral 500 mg tablets must not be presented as a substitute.
For institutional and B2B supply enquiries, request the current manufacturing authorization, approved product registration, batch-specific certificate of analysis, stability evidence, packaging specifications and applicable export documents. CTD/ACTD dossiers, COPP, FSC and WHO-GMP documentation should be described as available only after documentary confirmation.
Destination-country product registration, permitted indications, excipient rules and labeling must be checked before supply.
Q: Which strength is confirmed?
A: The supplied composition confirms Tranexamic Acid BP 500 mg in a film-coated tablet.
Q: What is its principal use?
A: Oral tranexamic acid is used to reduce heavy menstrual bleeding when prescribed appropriately.
Q: Is tranexamic acid an antiplatelet or blood-pressure medicine?
A: No. It is an antifibrinolytic that reduces breakdown of fibrin clots.
Q: Can these tablets be used for emergency postpartum hemorrhage?
A: No. Emergency postpartum hemorrhage requires immediate hospital care; relevant treatment protocols use intravenous administration.
Dose and treatment duration depend on the approved local product label, kidney function, patient age, clinical indication and risk factors. For heavy menstrual bleeding, oral treatment is generally taken only during menstruation for a limited number of days, as prescribed; it is not a continuous daily preventive treatment.
Renal impairment may require dose reduction because tranexamic acid is cleared predominantly by the kidneys. Patients should not self-adjust dosing or use the medicine for unexplained bleeding without assessment.
Possible side effects include nausea, vomiting, diarrhea and headache. Important precautions include a history or current presence of thrombosis, kidney impairment, visual or color-vision changes, and seizure risk in susceptible settings. Seek urgent medical attention for chest pain, breathlessness, leg swelling, sudden visual disturbance or signs of a serious allergic reaction.
Combined hormonal contraceptives can increase thrombotic risk when used with tranexamic acid; some product labels contraindicate the combination. Patients with active intravascular clotting or a history of thromboembolic disease require careful assessment against local contraindications. Tranexamic acid is not suitable for every cause of bleeding.
Store in the original, properly closed packaging and protect from excess moisture and heat. Follow the approved pack label for the exact temperature limit, expiry date and handling conditions; “below 30°C” requires confirmation from product-specific stability data.
Keep out of reach of children. Prescription-only use as required by local regulation.
For healthcare professional and B2B reference. Product availability, approvals, certifications, manufacturing processes, packaging and prescribing details must be verified for the relevant market.