Sirolisum Tablets 1mg

Sirolisum Tablets 1mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Sirolisum Tablet 1mg 

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Sirolisum Tablet 1mg
  Each Film-coated tablet contains:
  Sirolisum.…………………………….1mg
  Excipients…………………………… q.s
  Colours: Sunset Yellow  

THERAPEUTIC INDICATIONS:

Sirolimus is used in combination with other medications to prevent rejection of kidney transplants. Sirolimus is in a class of medications called immunosuppressants. It works by suppressing the body’s immune system.

CAUTION & WARNING:

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

SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber. 

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.
Do not freeze.
Keep the container tightly closed in order to protect from moisture.

Dosage: As directed by the Physician.

Introduction to Sirolisum Tablets 1mg

Sirolisum Tablets 1mg are a crucial immunosuppressive medication primarily used to prevent the body from rejecting transplanted organs, including kidneys, livers, and hearts. Sirolisum belongs to a class of medicines called mTOR inhibitors, which modulate the immune system, allowing the transplanted organ to be accepted as part of the body.

Following an organ transplant, the body’s immune system naturally attempts to attack foreign tissues. Sirolisum Tablets 1mg work by suppressing this immune response, reducing the risk of organ rejection while promoting the survival and function of the transplanted organ.

Globally, the demand for Sirolisum Tablets 1mg has surged due to the rising number of organ transplants, growing awareness of post-transplant care, and the need for reliable immunosuppressive therapy. Taj Pharma, a trusted manufacturer, exporter, and supplier from Vapi, Gujarat, India, ensures high-quality tablets that meet international standards and fulfill the needs of hospitals, pharmacies, and distributors worldwide.

In-depth Details for Importers, Exporters, and Buyers

1. Regulatory Documentation Provided

Taj Pharma provides complete regulatory documentation for seamless global trade:

• WHO-GMP and EU-GMP certifications

• Certificate of Pharmaceutical Product (CoPP)

• CTD Dossier and Drug Master File (DMF)

• Free Sale Certificates (FSC) for export compliance

• Stability and bioavailability studies as per ICH guidelines

This documentation ensures fast approvals and registration in international markets.

2. Custom Packaging & Labeling

Taj Pharma offers customizable packaging solutions for global distribution:

• Blister packs: Alu-Alu or PVC/PVDC strips

• Bottles and jars for bulk hospital supply

• Tamper-proof and child-resistant packaging

• Custom labeling in multiple languages for regulatory compliance

3. Shelf-Life, Storage, and Dosage Form

• Dosage Form: Oral tablet

• Strength: 1mg per tablet

• Shelf-life: 24–36 months

• Storage: Store below 25°C, in a dry place away from sunlight

• Administration: As prescribed by a transplant specialist, often in combination with other immunosuppressants like ciclosporin

4. Export Certifications

Taj Pharma’s Sirolisum Tablets 1mg meet stringent global standards:

• WHO-GMP & EU-GMP certification for quality assurance

• ISO 9001:2015 quality management certification

• CoPP & DMF dossiers for regulatory compliance

These certifications ensure that international buyers receive reliable, safe, and approved immunosuppressive tablets.

5. Target Countries & Export Markets

Taj Pharma exports Sirolisum Tablets 1mg to over 40 countries worldwide, including:

• Asia: Bangladesh, Nepal, Sri Lanka, Philippines, Vietnam

• Africa: Nigeria, Kenya, South Africa, Ghana, Uganda

• Middle East: UAE, Saudi Arabia, Oman, Qatar, Iraq

• Europe: Germany, Poland, Romania, Ukraine, Russia

• Latin America: Peru, Ecuador, Bolivia, Colombia, Chile

Taj Pharma’s robust logistics and regulatory support ensure smooth delivery to hospitals, pharmacies, and distributors in these regions.

Why is the Most Trusted Manufacturer, Supplier, and Exporter

1. State-of-the-Art Manufacturing

• WHO-GMP and EU-GMP certified facilities

• Automated production lines ensuring consistent tablet quality

• Advanced R&D and QC labs to monitor purity, potency, and stability

• Compliance with IP, BP, USP, and EP standards

2. Affordable Pricing & Quality Assurance

• Transparent and competitive pricing for bulk and institutional orders

• Stringent quality control at every stage of production

• Verified bioavailability and stability for consistent therapeutic efficacy

3. Global Presence & Supply Chain Support

• Strong distribution network across Asia, Africa, Europe, the Middle East, and Latin America

• End-to-end export assistance including documentation, logistics, and customs clearance

• Long-term partnerships with distributors, hospitals, and pharmacies

4. Top 20 Countries Exporting

India | UAE | Saudi Arabia | Oman | Kenya | Nigeria | South Africa | Ghana | Vietnam | Myanmar | Philippines | UK | Germany | France | Brazil | Chile | Peru | Colombia | Mexico | USA

Technical Product Specification  

Call to Action for Buyers & Distributors

If you are seeking a reliable Sirolisum Tablets 1mg manufacturer in India, Taj Pharma provides:

• WHO-GMP-certified immunosuppressant tablets

• Affordable pricing and bulk order support

• Complete regulatory documentation for global export

📞 Contact Taj Pharma today for quotations, export orders, and long-term supply partnerships.

Top 20 FAQs 

1. What are Sirolisum Tablets 1mg used for?
They prevent organ rejection after kidney, liver, or heart transplants.

2. Who is the leading manufacturer in India?
Taj Pharma, Vapi, Gujarat, a WHO-GMP-certified manufacturer.

3. Are these tablets exported globally?
Yes, Taj Pharma exports to 40+ countries worldwide.

4. What certifications are provided?
WHO-GMP, EU-GMP, ISO 9001:2015, CoPP, DMF.

5. How is Sirolisum administered?
Orally, usually under supervision of a transplant specialist.

6. What are the common side effects?
Herpes zoster, stomatitis, sepsis, kidney infection, CMV infection, decreased white blood cells, and rare allergic reactions.

7. Can Sirolisum be combined with ciclosporin?
Yes, but renal function should be closely monitored.

8. What is the shelf life?
24–36 months depending on storage conditions.

9. How should the tablets be stored?
Store in a cool, dry place below 25°C, away from sunlight.

10. Is Taj Pharma reliable for bulk orders?
Yes, with global supply chain support and PCD Pharma franchise options.

11. Are custom packaging options available?
Yes, including blister packs, bottles, and multilingual labeling.

12. Can hospitals and clinics purchase these tablets directly?
Yes, Taj Pharma serves hospitals, clinics, and pharmacies worldwide.

13. How should dosage be determined?
As prescribed by a transplant specialist based on patient condition.

14. Are these tablets safe during pregnancy?
Consult a doctor; typically used under strict medical supervision.

15. Can overdose occur?
Yes, follow the prescribed dose to prevent complications.

16. Are there any storage precautions?
Keep away from heat, moisture, and direct sunlight.

17. How can international buyers contact Taj Pharma?
Through the official website, email, or authorized sales representatives.

18. Does Taj Pharma provide regulatory support for importers?
Yes, including WHO-GMP certificates, CoPP, DMF, and CTD dossiers.

19. Can Sirolisum be supplied in institutional quantities?
Yes, for hospitals, clinics, and government tenders.

20. Is there a PCD Pharma franchise available?
Yes, Taj Pharma provides franchise opportunities nationwide and internationally.

Taj Pharma is the leading Sirolisum Tablets 1mg manufacturer in India, delivering high-quality, WHO-GMP-certified immunosuppressant tablets for organ transplant patients. With state-of-the-art manufacturing, robust global supply chain, competitive pricing, and complete regulatory support, Taj Pharma is the preferred choice for international buyers, hospitals, and distributors seeking reliable post-transplant medications.