Tacrolimus Capsules 0.5mg

Tacrolimus Capsules 0.5mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

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

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

D) Tacrolimus Capsules USP 5mg
Each hard gelatin Capsule contains:
Tacrolimus Monohydrate
Equivalent to Tacrolimus USP          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 & WARNING:

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

Warning: To be sold by retail on the prescription of a Nephrologist.

IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Protect from light and moisture.

Dosage: As directed by the Nephrologist

Attach dispensing label as per end county.

Introduction to Tacrolimus Capsules 0.5mg

Tacrolimus Capsules 0.5mg are an essential immunosuppressant medication widely prescribed to prevent organ rejection in patients who have undergone kidney, liver, heart, lung, or other organ transplants. Tacrolimus works by suppressing the body’s immune response, thereby reducing the risk of the immune system attacking the newly transplanted organ.

The lower-strength Tacrolimus Capsules 0.5mg play a crucial role in dose titration and long-term transplant management, especially in patients who require precise dose adjustments to maintain optimal therapeutic levels. With the global rise in organ transplant procedures and increasing survival rates, the demand for high-quality Tacrolimus Capsules 0.5mg has grown significantly across developed and emerging healthcare markets.

India has emerged as a preferred global sourcing hub for immunosuppressant medicines due to its strong regulatory framework, advanced manufacturing capabilities, and cost efficiency. Taj Pharma, a well-known Tacrolimus Capsules 0.5mg Manufacturer in India, ensures superior quality, high purity, and batch-to-batch consistency, making it a trusted partner for international buyers.

Trusted Tacrolimus Capsules 0.5mg Manufacturer in India

Taj Pharma Ltd India is a well-recognized Manufacturer, Exporter, and Supplier of Tacrolimus Capsules 0.5mg from Vapi, Gujarat, India. This medication belongs to a class of drugs known as immunosuppressants and is used along with other medicines to prevent the body from rejecting a transplanted organ such as a kidney, liver, or heart.

Tacrolimus weakens the immune system so it does not attack the new organ. As a leading Tacrolimus Capsules 0.5mg Supplier, Taj Pharma follows stringent WHO-GMP manufacturing standards, advanced quality control systems, and international regulatory norms to meet the expectations of global pharmaceutical markets.

Dosage, Administration & Important Safety Information

The dosage and frequency of Tacrolimus Capsules 0.5mg depend on several factors:

• Type of organ transplant

• Body weight

• Blood concentration levels

• Concomitant medications

Patients must strictly follow their physician’s instructions.

How to Take Tacrolimus Capsules 0.5mg

• Take on an empty stomach, at least 1 hour before or 2 hours after meals

• Take at the same time every day for consistent blood levels

• Swallow the capsule whole; do not crush or chew

• Continue treatment even if you feel well

Stopping Tacrolimus suddenly can significantly increase the risk of organ rejection.

Precautions & Warnings

Before starting Tacrolimus Capsules 0.5mg, inform your doctor if you have:

• Kidney, liver, or heart disease

• Diabetes or high blood pressure

Patients should also disclose all other medicines they are taking, particularly antibiotics, antifungals, pain medications, or arthritis drugs, as interactions may occur. Since immunosuppressants increase the risk of skin cancer, patients should minimize sun exposure and use protective measures such as sunscreen.

In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

As a reputed Tacrolimus Capsules 0.5mg Manufacturer & Supplier in India, Taj Pharma provides comprehensive regulatory and quality documentation, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• Certificate of Analysis (COA)

• Stability Data

• Material Safety Data Sheet (MSDS)

• CTD / eCTD Dossiers for product registration

Custom Packaging & Labeling

Taj Pharma offers flexible and customized packaging solutions to meet international market requirements:

• Alu-Alu and blister packaging

• HDPE bottle packaging

• Country-specific labeling compliance

• Multilingual artworks

• Private labeling and PCD Pharma Franchise support

Shelf Life, Storage & Dosage Form

• Dosage Form: Capsules

• Strength: 0.5mg

• Shelf Life: 24–36 months

• Storage Conditions: Store below 25°C, protect from light and moisture

Export Certifications

• WHO-GMP certified manufacturing facility

• ISO-compliant quality systems

• GDP-compliant logistics

• Pharmacovigilance and regulatory support

Target Countries & Export Markets

Tacrolimus Capsules 0.5mg export from India by Taj Pharma caters to a wide range of regulated and semi-regulated markets across:

• Asia

• Africa

• Middle East

• Europe

• Latin America

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

State-of-the-Art Manufacturing

• WHO-GMP certified modern manufacturing units

• Advanced capsule filling and packaging technology

• Strict in-process quality checks and validation

• Compliance with ICH and global pharmaceutical standards

Affordable Pricing & Quality Assurance

Taj Pharma combines cost-effective manufacturing with uncompromised quality, making it a leading Tacrolimus Capsules 0.5mg Manufacturer in India for global buyers seeking reliability and competitive pricing.

Global Presence & Supply Chain Support

• Strong distribution network across 20+ countries

• Cold-chain and temperature-controlled logistics

• Timely deliveries and consistent bulk supply

• End-to-end regulatory and documentation assistance

Top 20 Countries Exported by Taj Pharma

Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia

Technical Product Specification Table

PAN India & Global Market Presence

• Tacrolimus Capsules 0.5mg PAN India Manufacturer

• Tacrolimus Capsules 0.5mg Manufacturer Supplier and PCD Pharma Franchise

• Tacrolimus Capsules 0.5mg Manufacturer Vapi, Gujarat

• Leading #1 Tacrolimus Capsules 0.5mg Manufacturer & Supplier in India

• Tacrolimus Capsules 0.5mg Manufacturers, Exporters India

Call to Action 

If you are looking for a reliable Tacrolimus Capsules 0.5mg Manufacturer in India, Supplier, Exporter, or PCD Pharma Franchise Partner, Taj Pharma Ltd is your ideal global partner.

📩 Contact Taj Pharma Today
✔ Bulk supply & contract manufacturing
✔ Private labeling & franchise opportunities
✔ WHO-GMP certified products
✔ Competitive pricing & worldwide logistics

Top 20 FAQs  

1. What is Tacrolimus Capsules 0.5mg used for?
   To prevent organ rejection after transplant.

2. Is Taj Pharma WHO-GMP certified?
   Yes, Taj Pharma operates WHO-GMP certified facilities.

3. Does Taj Pharma export Tacrolimus globally?
   Yes, to over 20 countries.

4. Are private label options available?
   Yes.

5. What is the shelf life of Tacrolimus Capsules 0.5mg?
   24–36 months.

6. Should Tacrolimus be taken with food?
   Preferably on an empty stomach.

7. Can Tacrolimus interact with other drugs?
   Yes, consult a doctor.

8. Is Tacrolimus safe during pregnancy?
   Only if prescribed by a physician.

9. Does Taj Pharma provide CTD dossiers?
   Yes.

10. Is bulk procurement available?
    Yes.

11. Can hospitals purchase directly from Taj Pharma?
    Yes.

12. Does Tacrolimus increase infection risk?
    Yes, due to immune suppression.

13. What packaging options are available?
    Blisters and bottles.

14. Does Taj Pharma offer PCD Pharma Franchise?
    Yes, PAN India.

15. Is this medicine exported to Africa?
    Yes.

16. How should Tacrolimus Capsules be stored?
    Below 25°C, away from moisture.

17. Why choose Taj Pharma as a supplier?
    Quality, compliance, and global reliability.

18. Is it suitable for kidney transplant patients?
    Yes.

19. Does Taj Pharma support regulatory filings?
    Yes.

20. How can buyers contact Taj Pharma?
    Through official sales and export channels.