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 1mg 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 1mg
Tacrolimus Capsules 1mg are a potent immunosuppressant medication primarily prescribed to prevent organ rejection in patients who have received a kidney, liver, heart, or other organ transplant. Tacrolimus works by selectively suppressing the immune system, thereby preventing the body from attacking the transplanted organ.
Belonging to the class of drugs known as calcineurin inhibitors, Tacrolimus has become a gold-standard therapy in post-transplant care. The 1mg strength is especially important for dose titration, long-term maintenance therapy, and individualized patient management.
Global Demand for Tacrolimus Capsules 1mg
The global demand for Tacrolimus Capsules 1mg export from India continues to rise due to:
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Increasing number of organ transplants worldwide
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Improved transplant survival rates
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Rising access to advanced healthcare in developing countries
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Cost-effective, WHO-GMP–certified medicines from India
India is a preferred sourcing hub for immunosuppressants, and Taj Pharma plays a key role in meeting this international demand.
Trusted Tacrolimus Capsules 1mg Manufacturer in India
Taj Pharma, the well-known Tacrolimus Capsules 1mg Manufacturer in India, assures high quality, safety, and purity at every stage of production. Manufactured at its state-of-the-art facility in Vapi, Gujarat, Taj Pharma’s Tacrolimus Capsules 1mg comply with stringent national and international quality standards.
Taj Pharma Ltd India is a well-recognized Manufacturer, Exporter, and Supplier of Tacrolimus Capsules 1mg from Vapi, supplying both the domestic Indian market and global export destinations.
Therapeutic Uses & Mechanism of Action
Medical Uses
Tacrolimus Capsules 1mg are used:
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To prevent rejection after kidney, liver, heart, and other organ transplants
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As part of combination immunosuppressive therapy with corticosteroids or other agents
How Tacrolimus Works
Tacrolimus suppresses the immune system by inhibiting calcineurin, a key enzyme required for T-cell activation. This action prevents immune-mediated damage to the transplanted organ and supports long-term graft survival.
Dosage, Administration & Patient Guidance
Taj Pharma Ltd is a top known Manufacturer, Exporter, and Supplier of Tacrolimus Capsules 1mg from Vapi, Gujarat, India.
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Dosage varies depending on the type of transplant, patient weight, and concurrent medications
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Should be taken on an empty stomach, at least 1 hour before or 2 hours after meals
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Take the medicine regularly at the same time each day
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Do not discontinue without medical advice, as stopping therapy may result in organ rejection
Precautions & Safety Information
Before taking Tacrolimus Capsules 1mg, patients should inform their doctor if they have:
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Kidney, liver, or heart disease
-
Diabetes or high blood pressure
Patients should also disclose all medications they are taking, particularly antibiotics, antifungals, painkillers, and arthritis medicines, as Tacrolimus is prone to drug interactions.
Because immunosuppressants may increase the risk of skin cancer, patients are advised to limit sun and UV exposure and use protective measures.
In-Depth Details for Importers, Exporters & Buyers
Regulatory Documentation Provided
As a professional Tacrolimus Capsules 1mg Manufacturer & Supplier, Taj Pharma provides comprehensive regulatory support, including:
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WHO-GMP Certificate
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Certificate of Pharmaceutical Product (COPP)
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Free Sale Certificate (FSC)
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Certificate of Analysis (COA)
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Stability Studies
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Material Safety Data Sheet (MSDS)
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CTD / ACTD Dossiers for product registration
Custom Packaging & Labeling
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Blister packs, strip packs, and HDPE bottles
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Export-grade secondary and tertiary packaging
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Country-specific labeling and multilingual cartons
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Support for PCD Pharma Franchise branding
Shelf-Life, Storage & Dosage Form
-
Dosage Form: Capsules
-
Strength: 1mg
-
Shelf Life: 24–36 months
-
Storage Conditions: Store below 25°C, protect from light and moisture
Export Certifications
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WHO-GMP certified manufacturing facility
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COPP for regulated and semi-regulated markets
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CTD dossier support
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EU-GMP documentation assistance (on request)
Target Countries & Export Markets
Tacrolimus Capsules 1mg Manufacturers, Exporters India supply to:
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Africa
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Southeast Asia
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Middle East
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CIS countries
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Latin America
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Select European markets
Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter
State-of-the-Art Manufacturing
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Modern manufacturing unit in Vapi, Gujarat
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Advanced capsule filling and packing lines
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Strict in-process quality control
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Final product testing as per pharmacopeial standards
Affordable Pricing & Quality Assurance
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Competitive export pricing
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High-purity active pharmaceutical ingredients
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Consistent batch-to-batch quality
Global Presence & Supply Chain Support
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Strong logistics and export management team
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Timely shipments with reliable freight partners
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Dedicated regulatory and documentation support
Top 20 Countries Exporting
Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia
Technical Product Specification
| Parameter | Details |
|---|---|
| Product Name | Tacrolimus Capsules 1mg |
| Active Ingredient | Tacrolimus |
| Dosage Form | Capsules |
| Strength | 1mg |
| Therapeutic Category | Immunosuppressant |
| Packaging | Blister / Bottle |
| Shelf Life | 24–36 Months |
| Storage | Below 25°C |
| GMP Status | WHO-GMP Certified |
| Manufacturer | Taj Pharma Ltd, India |
PAN India Presence & PCD Pharma Franchise
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Tacrolimus Capsules 1mg PAN India Manufacturer
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Tacrolimus Capsules 1mg Manufacturer from Mumbai
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Tacrolimus Capsules 1mg Manufacturer Vapi, Gujarat
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Leading 1 Tacrolimus Capsules 1mg Manufacturer & Supplier in India
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Tacrolimus Capsules 1mg PCD Pharma Franchise / Manufacturer and Supplier
Call to Action
If you are looking for a trusted Tacrolimus Capsules 1mg Manufacturer Supplier in India, Taj Pharma Ltd is your ideal partner.
📞 Contact Taj Pharma today for:
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Bulk export orders
-
Hospital and institutional supply
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PCD Pharma Franchise opportunities
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Regulatory dossier and documentation support
Top 20 FAQs
-
What is Tacrolimus Capsules 1mg used for?
Prevention of organ rejection after transplant. -
Who is the leading manufacturer in India?
Taj Pharma Ltd. -
Is Taj Pharma WHO-GMP certified?
Yes. -
Is this product available for export?
Yes. -
What is the shelf life?
24–36 months. -
Can Taj Pharma provide COPP?
Yes. -
Is private labeling available?
Yes. -
Is it suitable for PCD Pharma Franchise?
Yes. -
How should it be taken?
On an empty stomach. -
Where is it manufactured?
Vapi, Gujarat, India. -
Are infections a risk?
Yes, due to immunosuppression. -
Does Taj Pharma support CTD dossiers?
Yes. -
Is bulk supply available?
Yes. -
Can it be used long term?
Under medical supervision. -
Does Taj Pharma export PAN India?
Yes. -
Are sun precautions necessary?
Yes. -
What packaging options are available?
Blister and bottle packs. -
Is dosage patient-specific?
Yes. -
Can it interact with other drugs?
Yes. -
How can buyers place an order?
By contacting Taj Pharma directly.






