Sirolisum Tablet 0.5mg FDA Manufacturers India, GMP Supplier

Sirolisum Tablets 0.5mg Technical Specification:

Product Name:	Sirolisum Tablet
Brand Name:	SIRLOTAJ
Strength:	(0.5mg), (1mg), (2mg)
Dosage Form:	Tablet (Film-coated)
Route of Administration:	Via oral Route
Packing:	10s, 30s, 100s
Pack Insert/Leaflet:	PIL (Patient Information Leaflet)
Regulatory Documents:	COA, MOA, Stability Studies, GMP
Therapeutic use:	Antimalarial
Indication:	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
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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Sirolisum Tablet 0.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Sirolisum Tablet 0.5mg
Each Film-coated tablet contains:
Sirolisum.…………………………….0.5mg
Excipients…………………………… q.s
Colours: Quinoline 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 0.5mg

Sirolisum Tablets 0.5mg are specialized immunosuppressive medications prescribed to prevent the rejection of transplanted organs such as kidneys, liver, and heart. Post-transplant, the body’s white blood cells recognize the new organ as foreign and attempt to reject it. Sirolimus helps suppress this immune response, allowing the transplanted organ to function effectively.

Globally, the demand for Sirolisum Tablets 0.5mg is increasing due to the rising number of organ transplants and the critical need for reliable immunosuppressive therapy. Healthcare providers, transplant centers, and distributors worldwide prefer high-quality, certified sirolimus tablets for consistent patient outcomes.

Taj Pharma has established itself as a trusted Sirolisum Tablets 0.5mg manufacturer in India, providing premium-quality tablets that meet global pharmaceutical standards.

In-Depth Details for Importers, Exporters, and Buyers

Taj Pharma ensures that international buyers receive Sirolisum Tablets 0.5mg with complete regulatory compliance, secure packaging, and quality assurance for seamless global distribution.

Regulatory Documentation Provided

WHO-GMP and EU-GMP certification
Certificate of Pharmaceutical Product (COPP)
CTD dossier for international regulatory approvals
Free Sale Certificates
Compliance with global standards including FDA, MHRA, and EMA

Custom Packaging & Labeling

Bottles, blister packs, and bulk packaging
Private labeling for distributors and franchise partners
Tamper-evident and child-resistant packaging options

Shelf-Life, Storage & Dosage Form

Shelf-life: 24–36 months
Storage: Store below 30°C; protect from moisture and light
Dosage Form: 0.5mg tablets
Dosage Guidelines: Administered under strict medical supervision post-transplantation

Export Certifications

WHO-GMP and EU-GMP compliant manufacturing
ISO 9001:2015 certified quality management system
Batch-specific quality assurance reports
Stability studies ensuring potency and safety

Target Countries & Export Markets

Taj Pharma exports Sirolisum Tablets 0.5mg to over 70 countries worldwide:

Africa: Nigeria, Kenya, South Africa, Ghana
Asia-Pacific: Bangladesh, Vietnam, Philippines, Myanmar
Middle East: UAE, Saudi Arabia, Oman, Qatar
Europe: Germany, Poland, Romania, Bulgaria
Latin America: Brazil, Mexico, Argentina

Why is the Most Trusted Manufacturer, Supplier, and Exporter

Taj Pharma is recognized as the leading Sirolisum Tablets 0.5mg manufacturer in India, offering exceptional quality, reliability, and global compliance.

State-of-the-Art Manufacturing

Advanced production facilities in Vapi, Gujarat
WHO-GMP and EU-GMP certified
In-house laboratories for quality testing

Affordable Pricing & Quality Assurance

Competitive pricing for bulk and wholesale orders
Pharmaceutical-grade raw materials
Regular testing for purity, potency, and stability

Global Presence & Supply Chain Support

Efficient logistics with timely international delivery
Assistance with customs clearance and documentation
Support for PCD pharma franchise partners across India

Top 20 Countries Exporting

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

Technical Product Specification Table

Parameter	Details
Product Name	Sirolisum Tablets 0.5mg
Dosage Form	Tablet
Strength	0.5 mg
Indications	Prevention of organ rejection post-transplant
Administration	Oral
Packaging Options	Bottles, blister packs, bulk packaging
Storage Conditions	Below 30°C, away from moisture and light
Shelf-life	24–36 months
Certifications Available	WHO-GMP, EU-GMP, ISO, COPP
Manufacturer	Taj Pharma, Vapi, Gujarat, India
Export Markets	Africa, Asia-Pacific, Middle East, Europe, Latin America

Call to Action for Buyers and Distributors

For importers, distributors, and healthcare providers seeking high-quality Sirolisum Tablets 0.5mg, Taj Pharma offers:

WHO-GMP certified manufacturing
International regulatory compliance
Private labeling and custom packaging options
Competitive bulk pricing and reliable supply

📞 Contact Taj Pharma today to secure premium immunosuppressive tablets for your business or distribution network.

Top 20 FAQs

Q1. What are Sirolisum Tablets 0.5mg used for?
They prevent the body from rejecting transplanted organs.

Q2. Who is the leading manufacturer in India?
Taj Pharma is a trusted Sirolisum Tablets 0.5mg manufacturer in India.

Q3. How does sirolimus work?
It suppresses immune responses to prevent organ rejection.

Q4. Can these tablets be exported globally?
Yes, Taj Pharma exports to over 70 countries.

Q5. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO 9001:2015, COPP, CTD dossier compliance.

Q6. Shelf-life of the tablets?
24–36 months depending on storage conditions.

Q7. Private labeling available?
Yes, for distributors and franchise partners.

Q8. Side effects?
May include mouth inflammation, infections, kidney issues, hypersensitivity, thrombosis, and more.

Q9. Recommended dosage?
Administered under strict medical supervision post-transplantation.

Q10. Can pregnant women take sirolimus?
Only under medical supervision due to immunosuppressive effects.

Q11. Storage conditions?
Store below 30°C, away from light and moisture.

Q12. Dosage form?
0.5mg oral tablets.

Q13. Monitoring required?
Yes, frequent renal and blood tests are recommended.

Q14. Can it be combined with other immunosuppressants?
Yes, often co-administered with ciclosporin under supervision.

Q15. PCD Pharma Franchise available?
Yes, across India.

Q16. Where is Taj Pharma located?
Vapi, Gujarat, India.

Q17. Drug interactions?
May interact with antifungals, antibiotics, and other immunosuppressants.

Q18. Alcohol interaction?
Avoid excessive alcohol during therapy.

Q19. What if symptoms worsen?
Consult a healthcare provider immediately.

Q20. Why choose Taj Pharma?
Ensures quality, efficacy, compliance, and global trust for international buyers.