Tacrolimus Capsules 5mg

Tacrolimus Capsules  5mg 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 5mg

Tacrolimus Capsules 5mg are an essential immunosuppressive medication widely used to prevent the body from rejecting transplanted organs such as kidneys, livers, hearts, and lungs. Tacrolimus belongs to a group of drugs known as calcineurin inhibitors, which reduce T-cell activity, thus suppressing the immune response against newly transplanted organs.

The capsules are often prescribed in combination with other immunosuppressants such as steroids, azathioprine, basiliximab, or mycophenolate mofetil to enhance transplant success rates.

With rising organ transplant procedures globally, the demand for Tacrolimus Capsules 5mg is rapidly increasing, making it a highly sought-after product for hospitals, clinics, distributors, and international pharmaceutical buyers.

Taj Pharma, recognized as a trusted Tacrolimus Capsules 5mg manufacturer in India, ensures premium-quality capsules, consistent formulation, and WHO-GMP certification, making it a preferred choice for global buyers.

Therapeutic Uses and Benefits

Primary Uses

• Prevents acute and chronic organ rejection

• Supports long-term graft survival

• Enhances the effectiveness of combination immunosuppressive therapy

Mechanism of Action

Tacrolimus binds to the cytoplasmic protein FKBP-12, forming a complex that inhibits calcineurin, a critical enzyme in T-cell activation. This suppresses the immune system’s attack on the transplanted organ, reducing the likelihood of rejection.

Dosage and Administration

• Oral capsules taken once or twice daily, preferably at the same time each day

• Administer on an empty stomach or as advised by the physician

• Regular monitoring of blood levels, liver, and kidney function is essential

• Do not discontinue suddenly to avoid organ rejection

Common Side Effects

• Headache

• Nausea, vomiting, diarrhea, constipation

• Stomach pain or heartburn

• Sleep disturbances (insomnia)

Precautions and Warnings

• Avoid grapefruit and grapefruit juice

• Consult your doctor if pregnant or breastfeeding

• Regularly monitor for signs of infection due to immune suppression

• Adjust dosage according to blood levels and organ function tests

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma offers complete regulatory compliance documentation, ensuring hassle-free import/export:

• Certificate of Analysis (CoA)

• WHO-GMP certification

• EU-GMP approval

• Certificate of Pharmaceutical Product (COPP)

• CTD Dossier for easy registration in international markets

Custom Packaging & Labeling

• Available in blister packs, strip packs, and bulk packaging

• Private labeling options for distributors and international buyers

• Packaging ensures capsule integrity and maximum shelf-life

Shelf-Life, Storage, and Dosage Form

Export Certifications

Taj Pharma complies with international standards:

• WHO-GMP certified manufacturing

• EU-GMP approved production facilities

• COPP certified for international distribution

• CTD Dossier for regulatory approval

These certifications assure buyers that all Tacrolimus Capsules 5mg meet global quality standards.

Target Countries & Export Markets

Taj Pharma exports Tacrolimus Capsules 5mg 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

Efficient logistics ensure safe and timely delivery, maintaining product quality throughout the supply chain.

Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing

• Advanced facility in Vapi, Gujarat

• Highly automated production lines for uniform capsule quality

• Stringent quality control labs for testing every batch

Affordable Pricing & Quality Assurance

• Competitive pricing for bulk orders and international buyers

• Consistently high-quality, WHO-GMP certified products

• Transparent and reliable supply chain management

Global Presence & Supply Chain Support

• Extensive PCD Pharma franchise network across India

• International logistics for safe and fast delivery

• Full regulatory and documentation support for global exports

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 Table: 

• Bulk orders for hospitals, pharmacies, and distributors

• Private-label packaging for international clients

• PCD Pharma franchise opportunities available across India

• Full logistics, regulatory, and documentation support

Contact Taj Pharma today for a reliable, WHO-GMP certified supply of Tacrolimus Capsules 5mg.

Top 20 FAQs 

1. What is Tacrolimus used for?
   Prevents organ rejection after 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 5mg?
   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 5mg?
    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.