GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Tacrolimus Capsules USP 1mg
C) Tacrolimus Capsules USP 2mg
D) Tacrolimus Capsules USP 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
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:
CAUTION & WARNING:
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:
Protect from light and moisture.
Dosage: As directed by the Nephrologist
Attach dispensing label as per end county.
Tacrolimus Capsules 5mg Technical Specification:
| Product Name: | Tacrolimus Capsules USP |
| Brand Name: | TACROTAJ |
| Strength: | 0.5mg, 1mg, 2mg, 5mg |
| Dosage Form: | Capsules(Hard gelatin) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Immunosuppressants |
| Indication: | Tacrolimus is an immunosuppressive drug. After allogeneic organ transplant, the risk of organ rejection is moderate. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Protect from light and moisture. |
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 5mg
Tacrolimus Capsules 5mg is a potent immunosuppressant medication widely prescribed to prevent organ rejection in patients who have undergone kidney, liver, or heart transplantation. It belongs to the calcineurin inhibitor class of drugs and works by suppressing the body’s immune response, allowing the transplanted organ to be accepted as part of the body rather than attacked as a foreign substance.
Due to the increasing number of organ transplant procedures worldwide, the global demand for Tacrolimus Capsules 5mg has grown significantly. Rising incidences of chronic kidney disease, liver failure, and advancements in transplant medicine have made Tacrolimus a critical therapy in post-transplant care. As a result, Tacrolimus Capsules 5mg export from India has become a key focus area for international buyers seeking reliable, cost-effective, and high-quality sources.
Taj Pharma, a well-known Tacrolimus Capsules 5mg Manufacturer in India, assures global buyers of superior quality, purity, and compliance with international regulatory standards. Manufactured under stringent quality systems, Taj Pharma’s Tacrolimus Capsules 5mg meet the expectations of regulated and semi-regulated markets worldwide.
About Tacrolimus Capsules 5mg – Uses & Therapeutic Importance
Tacrolimus Capsules 5mg is primarily used to:
-
Prevent organ rejection after kidney, liver, or heart transplantation
-
Maintain long-term graft survival
-
Manage immune-mediated conditions under strict medical supervision
In transplant patients, Tacrolimus suppresses the immune system by inhibiting T-lymphocyte activation. This action prevents the immune system from attacking the transplanted organ. It is a prescription-only medicine requiring regular monitoring due to potential side effects and drug interactions.
Taj Pharma is a well-established Manufacturer, Exporter, and Supplier of Tacrolimus Capsules 5mg from Vapi, Gujarat, India, delivering consistent quality and therapeutic efficacy to international markets.
Side Effects & Safety Information
Like all immunosuppressants, Tacrolimus Capsules 5mg may cause side effects, especially when not properly monitored. Common and reported side effects include:
-
Increased blood glucose levels
-
Insomnia
-
Increased potassium levels
-
High blood pressure
-
Renal toxicity
-
Neurotoxicity
-
Gastrointestinal disorders
-
Diabetes
-
Infections
-
Decreased appetite
-
Electrolyte imbalance
-
Fluid overload
-
Blood cell abnormalities
Patients are advised to take this medicine exactly as prescribed. Regular blood tests are essential to monitor Tacrolimus levels, kidney function, and blood cell counts. Inform your doctor immediately if you experience unexplained bruising, bleeding, sore throat, fever, or general illness.
In-Depth Details for Importers, Exporters & Global Buyers
Regulatory Documentation Provided
Taj Pharma supports international buyers with comprehensive regulatory documentation, including:
-
Certificate of Pharmaceutical Product (COPP)
-
Certificate of Analysis (COA)
-
Batch Manufacturing Records (BMR)
-
Stability data
-
Drug Master File (DMF) support (on request)
Custom Packaging & Labeling
As a trusted Tacrolimus Capsules 5mg Supplier, Taj Pharma offers:
-
Customized blister or bottle packaging
-
Private labeling & brand support
-
Multilingual labeling as per importing country regulations
Shelf-Life, Storage & Dosage Form
-
Dosage Form: Hard gelatin capsules
-
Strength: 5mg
-
Shelf Life: Typically 24 months
-
Storage: Store below 25°C, protected from moisture and light
Export Certifications
Taj Pharma holds and supports:
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WHO-GMP certification
-
EU-GMP compliant manufacturing processes
-
COPP
-
CTD Dossier (Modules 1–5 support)
Target Countries & Export Markets
Taj Pharma exports Tacrolimus Capsules 5mg to:
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Asia
-
Africa
-
CIS countries
-
Middle East
-
Latin America
-
Selected regulated markets
Why Taj Pharma is the Most Trusted Tacrolimus Capsules 5mg Manufacturer in India
State-of-the-Art Manufacturing
Taj Pharma operates advanced manufacturing facilities in Vapi, Gujarat, equipped with modern machinery, cleanroom environments, and validated processes that ensure batch-to-batch consistency.
Affordable Pricing & Quality Assurance
India’s cost-efficient manufacturing ecosystem allows Taj Pharma to offer competitive pricing without compromising quality. Every batch undergoes strict quality control and assurance checks.
Global Presence & Supply Chain Support
With a strong logistics network and export expertise, Taj Pharma ensures timely delivery, proper documentation, and regulatory compliance for global buyers.
Top 20 Countries Exporting
India | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile
Technical Product Specification Table
| Parameter | Details |
|---|---|
| Product Name | Tacrolimus Capsules 5mg |
| Active Ingredient | Tacrolimus |
| Strength | 5mg |
| Dosage Form | Capsule |
| Therapeutic Class | Immunosuppressant |
| Indication | Organ transplant rejection prevention |
| Shelf Life | 24 months |
| Storage | Below 25°C |
| Manufacturing Standard | WHO-GMP |
| Country of Origin | India |
PAN India Presence & Franchise Opportunities
Taj Pharma is recognized as:
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Tacrolimus Capsules 5mg PAN India Manufacturer
-
Tacrolimus Capsules 5mg Manufacturer Supplier and PCD Pharma Franchise
-
Tacrolimus Capsules 5mg Manufacturer in Mumbai & Vapi, Gujarat
-
Leading Tacrolimus Capsules 5mg Manufacturer & Supplier in India
The company offers attractive PCD Pharma Franchise opportunities with marketing support, monopoly rights, and consistent supply.
Call to Action
If you are looking for a reliable Tacrolimus Capsules 5mg Manufacturer in India, Taj Pharma is your ideal partner. With proven export expertise, regulatory support, and consistent quality, we help global buyers succeed in their markets.
👉 Contact Taj Pharma today to request samples, pricing, dossiers, or long-term supply agreements.
Top 20 FAQs
-
What is Tacrolimus Capsules 5mg used for?
It is used to prevent organ rejection after transplantation. -
Is Tacrolimus Capsules 5mg safe?
Yes, when taken under strict medical supervision. -
Who should not take Tacrolimus?
Patients with hypersensitivity or severe infections without medical advice. -
Does Taj Pharma export Tacrolimus Capsules 5mg?
Yes, worldwide. -
What certifications does Taj Pharma have?
WHO-GMP, COPP, CTD support. -
What is the shelf life?
Usually 24 months. -
Can Taj Pharma provide private labeling?
Yes. -
Is it available for PCD Pharma Franchise?
Yes. -
How should it be stored?
Below 25°C, away from moisture. -
Is blood monitoring required?
Yes, regularly. -
Can it cause kidney problems?
Possible, monitoring is essential. -
Is it suitable for long-term use?
Only if prescribed by a doctor. -
Does Taj Pharma supply PAN India?
Yes. -
Is export documentation provided?
Yes. -
What packaging options are available?
Blister and bottle packs. -
Is Tacrolimus a prescription drug?
Yes. -
Can it interact with other medicines?
Yes, inform your doctor. -
What markets does Taj Pharma serve?
Asia, Africa, Middle East, CIS, Latin America. -
Is Taj Pharma a trusted exporter?
Yes, globally recognized. -
How to contact Taj Pharma?
Through official inquiry channels for export & franchise.






