Description
Azathioprine Tablets (50mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Azathioprine Tablets in India. This potent immunosuppressant is critical for preventing organ rejection in transplant patients and treating severe autoimmune disorders. We produce high-purity, film-coated tablets in a dedicated cytotoxic containment facility. Our operations adhere to strict WHO-GMP standards to ensure safety and efficacy. Healthy Inc manages our global exports and transplant center tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Azathioprine Tablets | | Generic Name | Azathioprine USP / BP / IP | | Strength | 25mg / 50mg / 75mg / 100mg | | Dosage Form | Film Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Immunosuppressant (Antimetabolite) | | Shelf Life | 36 Months | | Packaging | 10×10 Blister / 100s HDPE Bottle |
3. Manufacturing Azathioprine Tablets We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Since Azathioprine is a Cytotoxic Drug, we manufacture it in a Dedicated Containment Suite. This prevents any cross-contamination with other general medicines. We use robust Film Coating technology to seal the tablet core, ensuring that pharmacists and patients are not exposed to drug dust when handling the medication.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Azathioprine Tablets. We supply renal (kidney) transplant centers and rheumatology clinics globally. We are experienced in handling the specialized shipping documentation required for hazardous medicinal products.
4. Quality Assurance We test every batch rigorously.
Content Uniformity: We test individual tablets to ensure precise dosing, which is vital for maintaining the delicate balance of immune suppression.
Dissolution: We test how the tablet releases the drug. Consistent bioavailability is critical to prevent graft rejection.
Impurity Profiling: We monitor for degradation products to ensure the drug remains stable over its shelf life.
5. Why Use Azathioprine Tablets? This drug suppresses the body’s overactive immune response.
Mechanism: It is converted into 6-mercaptopurine in the body. This metabolite inhibits DNA synthesis in T-cells and B-cells (immune cells).
Effect: It stops the immune system from attacking a transplanted organ or the body’s own tissues (in autoimmune disease).
Key Indications:
Organ Transplant: Prevention of rejection in Kidney, Liver, and Heart transplants (often used with Steroids and Cyclosporine).
Rheumatoid Arthritis: Treatment of severe, active RA unresponsive to other agents.
Autoimmune Diseases: Lupus (SLE), Inflammatory Bowel Disease (Crohn’s/Colitis), and Chronic Active Hepatitis.
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF.
7. Frequently Asked Questions
Q: Who manufactures Azathioprine Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Is this safe for pregnant women? A: It is generally contraindicated, but may be used if the benefit outweighs the risk (e.g., to prevent organ rejection).
Q: Why is the tablet coated? A: To protect the handler from direct contact with the cytotoxic drug and to mask the taste.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Transplant: Dosage depends on body weight, usually starting at 3-5 mg/kg/day, then adjusted for maintenance.
TPMT Testing: Patients should ideally be tested for TPMT enzyme deficiency before starting, as deficiency increases the risk of severe toxicity.
Administration: Take with food to reduce nausea.
9. Side Effects and Precautions
Bone Marrow Suppression: The most serious side effect is Leukopenia (low white blood cells) and Thrombocytopenia (low platelets). Regular blood counts are mandatory.
Infection Risk: Patients are more susceptible to viral, fungal, and bacterial infections.
Carcinogenicity: Long-term use may slightly increase the risk of skin cancers and lymphoma. Sun protection is advised.
10. Storage Instructions
Store below 25°C in a dry place.
Light Sensitive: Protect from light. Keep in the original container.
Keep out of reach of children.
