Tacrolimus Capsules 2mg

Tacrolimus Capsules 2mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Tacrolimus Capsules IP 0.5mg
B) Tacrolimus Capsules IP 1mg
C) Tacrolimus Capsules IP 2mg
D) Tacrolimus Capsules IP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tacrolimus Capsules IP 0.5mg
Each hard gelatin Capsule contains:
Tacrolimus Monohydrate
Equivalent to Tacrolimus IP………0.5mg
Excipients………………………………….q.s.
Approved colours used in capsule shell.

B) Tacrolimus Capsules IP 1mg
Each hard gelatin Capsule contains:Tacrolimus Monohydrate
Equivalent to Tacrolimus IP……..1mg
Excipients…………………………………q.s.
Approved colours used in capsule shell.

C) Tacrolimus Capsules IP 2mg
Each hard gelatin Capsule contains:
Tacrolimus Monohydrate
Equivalent to Tacrolimus IP……….2mg
Excipients…………………………………..q.s.
Approved colours used in capsule shell.

D) Tacrolimus Capsules IP 5mg
Each hard gelatin Capsule contains:
Tacrolimus Monohydrate
Equivalent to Tacrolimus IP………5mg
Excipients………………………………….q.s.
Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

Tacrolimus is used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney, liver, heart, or lung). This medicine may be used with steroids, azathioprine, basiliximab, or mycophenolate mofetil. Tacrolimus belongs to a group of medicines known as immunosuppressive agents.

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: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A Nephrologist.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light.
Dosage: As directed by the Nephrologist.

Introduction to Tacrolimus Capsules 2mg

Tacrolimus Capsules 2mg are a vital immunosuppressive medication used to prevent organ rejection after transplant procedures such as kidney, liver, heart, or lung transplants. Tacrolimus works by suppressing the activation of T-lymphocytes, thereby reducing the body’s immune response against the transplanted organ.

When combined with other immunosuppressants like steroids, azathioprine, basiliximab, or mycophenolate mofetil, Tacrolimus Capsules 2mg ensure the optimal survival and function of the transplanted organ.

Globally, the demand for Tacrolimus has increased significantly, driven by rising organ transplant procedures, enhanced post-transplant care, and growing awareness among healthcare professionals. This makes Tacrolimus Capsules 2mg a high-demand product for hospitals, distributors, and international pharma companies.

Taj Pharma, a renowned Tacrolimus Capsules 2mg manufacturer in India, ensures premium-quality, WHO-GMP certified products, establishing trust among global buyers and importers.

Therapeutic Uses and Benefits

Tacrolimus Capsules 2mg are prescribed to:

• Prevent acute and chronic organ rejection

• Serve as part of a combination therapy with other immunosuppressants

• Support long-term organ transplant success

Mechanism of Action

Tacrolimus binds to the cytoplasmic protein FKBP-12, forming a complex that inhibits calcineurin, a key enzyme in T-cell activation. This suppresses the immune response, reducing the risk of the body attacking the transplanted organ.

Dosage and Administration

• Take capsules orally with water, at the same time every day

• Follow your transplant specialist’s instructions carefully

• Do not abruptly discontinue, as this may lead to organ rejection

• Monitor blood levels and organ function regularly

Common Side Effects

• Headache

• Nausea, vomiting, diarrhea, or constipation

• Heartburn or stomach pain

• Difficulty sleeping (insomnia)

Precautions and Warnings

• Avoid grapefruit and grapefruit juice

• Pregnant or breastfeeding patients should consult a doctor

• Immediately report unusual symptoms such as infections, fever, or mood changes

• Regular blood tests are essential for long-term therapy

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma offers comprehensive documentation for smooth international trade:

• Certificate of Analysis (CoA)

• WHO-GMP certification

• EU-GMP approval

• Certificate of Pharmaceutical Product (COPP)

• CTD Dossier for easy registration in target countries

Custom Packaging & Labeling

• Blister packs, strip packs, and bulk packaging available

• Private labeling options for distributors

• Ensures capsule stability and maximum shelf-life

Shelf-Life, Storage, and Dosage Form

Export Certifications

Taj Pharma ensures international compliance with:

• WHO-GMP certified production

• EU-GMP approved facilities

• COPP compliant

• CTD dossier for regulatory approval in export markets

These certifications provide assurance to buyers and distributors that all products meet international quality standards.

Target Countries & Export Markets

Tacrolimus Capsules 2mg are exported to over 20 countries, including:

• USA, UK, Germany, Australia

• UAE, Saudi Arabia, South Africa, Canada

• Singapore, New Zealand, Kenya, Nigeria

• Bangladesh, Sri Lanka, Philippines, Malaysia

• Russia, Egypt, Thailand, Indonesia

Taj Pharma’s efficient logistics network ensures timely delivery while maintaining product integrity and compliance with regulatory requirements.

Why is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing

• Advanced facility in Vapi, Gujarat

• High-precision quality control labs

• Modern machinery ensures uniform capsule quality

Affordable Pricing & Quality Assurance

• Competitive rates for bulk and retail orders

• Premium-quality, WHO-GMP certified products

• Transparent supply chain management

Global Presence & Supply Chain Support

• Extensive PCD Pharma franchise network across India

• International logistics for fast and safe delivery

• Full regulatory documentation for smooth global export

Top 20 Countries Exporting

UAE || Saudi || Arabia || Oman || Qatar || Kuwait || Nigeria || Kenya || Ghana || South Africa || Egypt || Germany || France || UK || Italy || Spain || Sri Lanka || Myanmar Malaysia || Philippines || Vietnam

Technical Product Specification Table: 

• Bulk orders for hospitals, pharmacies, and distributors

• Private-label packaging for international clients

• PCD Pharma franchise opportunities across India

• Full logistics, regulatory, and documentation support

Contact Taj Pharma today for a reliable, WHO-GMP certified supply of Tacrolimus Capsules 2mg.

Top 20 FAQs  

1. What is Tacrolimus used for?
   Prevents organ rejection post-transplant.

2. Can it be combined with other medicines?
   Yes, often with steroids, azathioprine, basiliximab, or mycophenolate mofetil.

3. Common side effects?
   Headache, nausea, vomiting, diarrhea, constipation, heartburn, insomnia.

4. How should it be taken?
   Oral capsules, at the same time daily, as prescribed.

5. Can Tacrolimus be stopped suddenly?
   No, abrupt discontinuation may lead to organ rejection.

6. Shelf-life of Tacrolimus Capsules 2mg?
   24 months from manufacturing.

7. Is it safe during pregnancy?
   Only under medical supervision.

8. Available packaging options?
   Blister packs, strip packs, and bulk packaging.

9. Do I need regular monitoring?
   Yes, kidney and liver function tests are necessary.

10. PCD franchise available?
    Yes, across India.

11. Private labeling available?
    Yes, for international distributors.

12. Who can take Tacrolimus Capsules 2mg?
    Only transplant patients under doctor supervision.

13. Can it interact with food?
    Avoid grapefruit; take capsules with water.

14. Export countries?
    Over 20 countries worldwide.

15. Is Taj Pharma WHO-GMP certified?
    Yes, all products meet international standards.

16. Does it increase infection risk?
    Yes, due to immune suppression.

17. Can children take it?
    Only under pediatric transplant specialist guidance.

18. Dosage adjustments needed?
    Yes, based on blood levels and organ function.

19. How to order from Taj Pharma?
    Contact via email or phone for bulk or franchise orders.

20. Is long-term use safe?
    Yes, under medical supervision and regular monitoring.