Tacrolimus Capsules
| Product/Composition:- | Tacrolimus Capsules |
|---|---|
| Strength:- | 0.5mg, 1mg, 2mg, 3mg |
| Form:- | Capsules |
| Packaging:- | 10 X 10 Capsules / Box |
| Therapeutic use:- | Anti Cancer |
| Production Capacity:- | 10 Million Capsule/Month |
| Package Insert/Leaflet:- | Available upon request |
Introduction
Tacrolimus is a narrow therapeutic index (NTI) medicine, so our bioequivalence package is built to the tightened acceptance criteria that transplant regulators apply.
Complete CTD, ACTD and eCTD dossiers, CoPP, FSC and ICH Zone IVb stability data are supplied for direct MOH registration.
Product Overview Table
| Field | Details |
| Product Name | Tacrolimus Capsules |
| INN / Generic Name | Tacrolimus (as tacrolimus monohydrate) |
| Therapeutic Class | Calcineurin inhibitor immunosuppressant (macrolide lactone) |
| Mechanism (brief) | Binds FKBP-12; the resulting complex inhibits calcineurin, suppressing T-lymphocyte activation |
| Indications | Prophylaxis of organ rejection in kidney, liver and heart transplant recipients, in combination regimens |
| API Quality | Manufactured using DMF-grade Tacrolimus fermentation-derived |
| Pharmacopoeial Standard | USP Tacrolimus Capsules USP; Ph. Eur. monograph exists for the drug substance |
| Available Strengths | 0.5 mg, 1 mg, 5 mg (immediate-release capsules) |
| Dosage Forms | Immediate-release hard capsules; prolonged-release capsules |
| Therapeutic Index | Narrow Therapeutic Index (NTI) tightened BE criteria apply; see Section 5B |
| BCS Classification | Class II low solubility, high permeability (no biowaiver available) |
| Formulation Note | Amorphous solid dispersion; amorphous-form stability across shelf life is a critical quality attribute |
| Shelf Life | 24 Months |
| Storage | Store below 25°C, protected from moisture. Keep in original blister until use. |
| Manufacturing Facility | WHO-GMP certified contained block for potent compounds, with dedicated AHU |
| Safety Labelling | Boxed warning serious infections and malignancies including lymphoma; specialist prescriber requirement |
| Monitoring | Whole-blood trough level monitoring is standard clinical practice; see Section 5F |
| Dossier Available | Yes, CTD / ACTD / eCTD format |
| Regulatory Documents | CoA, CoPP, FSC, MOA, GMP Certificate, Stability Data, NTI-grade BE Study Report, HBEL Assessment |
Product Variants, Dosage Forms & Strengths
Tacrolimus Capsules 1 mg
The core maintenance strength and the highest-volume presentation in most transplant formularies.
Supplied as hard capsules with strength-differentiated print and colour coding, which matters more here than on an ordinary generic because patients take multiple strengths simultaneously during titration and misidentification has direct clinical consequences.
Tacrolimus Capsules 0.5 mg
The fine-titration strength, used to adjust dosing against whole-blood trough levels and in paediatric and low-weight patients.
At 0.5 mg this is a genuinely low-dose product, and content uniformity not assay is the principal quality risk.
Our release testing addresses uniformity at batch level rather than relying on end-of-run sampling.
Tacrolimus Capsules 5 mg
The high-strength presentation, used in the early post-transplant period and in patients requiring higher total daily doses, including rapid metabolisers.
Reduces capsule burden for patients already managing a multi-drug immunosuppressive regimen.
Prolonged-Release Presentation
CRITICAL: Immediate-release and prolonged-release tacrolimus are NOT interchangeable on a milligram-for-milligram basis, and conversion between them requires clinical supervision and re-titration against blood levels.
If this sub-section is published, that statement must appear with it.
If the product is not manufactured, delete the sub-section entirely do not leave it as an aspirational listing.
Pharmacopoeial Compliance
USP: Tacrolimus Capsules USP is the finished-product specification most widely requested for export
Ph. Eur.: a monograph exists for the drug substance, supporting European-referencing markets
BP / IP: confirm applicability to your SKU before claiming compliance
Beyond the standard monograph tests, our specification controls the amorphous state of the drug substance in the finished capsule.
Tacrolimus is poorly water soluble and is formulated as a solid dispersion; if the amorphous form recrystallises over shelf life, dissolution falls and systemic exposure changes.
On a narrow therapeutic index medicine that is a clinical event, not a specification deviation, which is why stability testing includes solid-state characterisation rather than assay and dissolution alone.
Regulatory & Dossier Support
Dossier Availability
CTD (Common Technical Document): ICH-aligned, for regulated and semi-regulated markets
ACTD (ASEAN Common Technical Dossier): Philippines, Vietnam, Myanmar, Indonesia, Cambodia
eCTD: for authorities mandating electronic submission
Module 3 quality documentation including solid dispersion process validation, solid-state characterisation, low-dose blend and content uniformity, dissolution method validation and moisture control strategy
Stability data: real-time and accelerated under ICH Zone IVb (30°C / 75% RH), with solid-state stability confirming no recrystallisation across shelf life
Country-specific dossier customisation and regulatory query response support included
Bioequivalence for a Narrow Therapeutic Index Drug Criteria Differ by Authority
Tacrolimus is classified as a narrow therapeutic index (NTI) drug, and it is BCS Class II, so no biowaiver route exists.
In-vivo bioequivalence is mandatory but unlike an ordinary generic, the acceptance criteria are tightened, and they are not tightened the same way everywhere.
A BE package that satisfies one authority may not satisfy another, which is why the first question we ask is which market you are registering in.
| Authority | AUC Acceptance Criteria | Cmax Acceptance Criteria |
| EMA | 90.00 – 111.11% (narrowed) | 80.00 – 125.00% – for tacrolimus specifically the narrow interval is Not applied to Cmax |
| Health Canada | 90.00 – 112.00% (narrowed) | 80.00 – 125.00% |
| US FDA | Scaled average BE (reference-scaled), fully replicated design | Reference-scaled criterion applied to Cmax as well as AUC |
| South Africa; Japan (PMDA) | 80.0 – 125.0% (conventional) | 80.0 – 125.0% (conventional) |
Why EMA relaxes Cmax for this molecule: total exposure measured by AUC is what governs safe dose titration, and tacrolimus accumulates across repeated dosing with a long terminal half-life, so differences in initial peak concentration matter less at steady state
Why the FDA route is different in kind: the reference-scaled approach requires a fully replicated design in which both the test and reference products are administered twice to each subject, and the product must pass both the reference-scaled limits and the unscaled 80.00 – 125.00% limits, with an additional constraint on the ratio of within-subject variability between test and reference
The practical consequence, and the reason this matters commercially: tacrolimus has within-subject variability approaching 30%, which puts it in highly-variable territory.
Published analysis indicates a conventional design would require at least around 40 subjects, while demonstrating compliance with the narrower EMA limits may require substantially larger studies.
The cost gap between a BE package built for a conventional-criteria market and one built for EMA criteria is an order of magnitude, not a margin.
Drug Master File (DMF)
Drug Master File (DMF) reference for the Tacrolimus API available for cross-referencing in your registration dossier
Fermentation-derived API sourced against a qualified vendor with full impurity, related-substance and solid-state characterisation
CDSCO / Indian DMF reference accepted by a large number of importing authorities shortens query cycles
Manufacturing Compliance
WHO-GMP certified manufacturing facility, audit-ready, with inspection reports shared on an NDA basis
Site Master File (SMF) available for regulatory submissions
Manufactured in a contained block with dedicated air handling and segregation appropriate to a potent immunosuppressant, with operator protection controls documented alongside product-quality controls
Low-dose uniformity controls: at 0.5 mg, blend homogeneity and content uniformity are the governing quality risks, and are demonstrated at batch level rather than inferred from assay
Solid dispersion manufacturing controlled against defined process parameters, because the amorphous state is generated in-process and cannot be corrected by downstream testing
Validated cleaning against a health-based exposure limit, with HBEL / Permitted Daily Exposure authored by a qualified toxicologist
Compliant with the requirements of FDA Philippines, DRAP (Pakistan), INVIMA (Colombia) and relevant Gulf and CIS authorities
Complete Documentation Package (Per Shipment)
| Document | Purpose |
| Certificate of Analysis (CoA) | Confirms batch quality against the agreed specification |
| Certificate of Pharmaceutical Product (CoPP / CPP) | Required for MOH registration in most importing countries |
| Free Sale Certificate (FSC) | Confirms the product is freely sold in the country of manufacture |
| Method of Analysis (MOA) | Analytical methodology mandatory dossier component |
| GMP Certificate | Confirms manufacturing site compliance, including the contained block |
| Stability Data | Real-time and accelerated ICH Zone IVb, plus solid-state stability |
| BE Study Report (NTI criteria) | States explicitly which authority’s acceptance criteria the study was powered against |
| Content Uniformity Data | Batch-level the governing quality risk at 0.5 mg strength |
| Solid-State Characterisation | Confirms amorphous form is maintained across shelf life |
| Dissolution Profile Report | Discriminatory method the performance parameter for a Class II drug |
| HBEL / PDE Assessment | Toxicologist-authored exposure limit underpinning cleaning acceptance criteria |
| Excipient Declarations | For all inactive ingredients, including capsule shell origin |
| BSE/TSE Declaration | For gelatin capsule shells; HPMC shells available as a non-animal alternative |
Therapeutic Drug Monitoring & Substitution Policy
Tacrolimus dosing is titrated against whole-blood trough concentrations, not fixed by body weight alone so any change of product is managed clinically with monitoring, never as a silent substitution
Many authorities restrict automatic substitution for NTI immunosuppressants and expect prescribing and dispensing by specific product; confirm the substitution policy in each target market before building a commercial strategy around switching
Commercial consequence: adoption runs through transplant-centre clinical committees and formulary review, on a longer cycle than a tender, and it depends on documentation quality and supply reliability rather than on unit price
Supply continuity is a clinical requirement here. A transplant patient is on maintenance immunosuppression indefinitely, and an interruption is a graft-rejection risk we plan against committed annual forecasts rather than reactive ordering
Clinical Indications & Therapeutic Information
Tacrolimus is a calcineurin inhibitor immunosuppressant.
It binds the intracellular protein FKBP-12, and the resulting complex inhibits calcineurin, blocking the signalling pathway that drives T-lymphocyte activation the mechanism underlying its use in preventing graft rejection.
Principal indication: prophylaxis of organ rejection in kidney, liver and heart transplant recipients, used as part of a combination immunosuppressive regimen rather than as monotherapy
A boxed warning applies, covering increased susceptibility to serious infections and an increased risk of malignancies including lymphoma, together with the requirement that the medicine be prescribed by physicians experienced in immunosuppressive therapy and transplant management. This must appear in full in leaflet and artwork.
Tacrolimus is a CYP3A4 and P-glycoprotein substrate with an extensive interaction profile; the interaction section of the leaflet is unusually consequential for this molecule and must not be abbreviated for space
Absorption is affected by food, so labelling directs consistent administration with respect to meals a labelling instruction that carries real exposure consequences on an NTI medicine
Market structure: demand is a function of transplant programme capacity rather than population size.
Volumes per market are modest compared with a general hospital generic, but each patient represents indefinite maintenance therapy, so the revenue profile is long-tail and highly retentive once a centre adopts a product.
Export Packaging & Supply Chain
Primary Packaging Options
| Presentation | Packaging Options |
| Tacrolimus Capsules 0.5 mg | Alu-Alu blister 10×10, moisture-protective, in mono-carton with leaflet |
| Tacrolimus Capsules 1 mg | Alu-Alu blister 10×10 and 6×10; HDPE bottle of 100 with desiccant |
| Tacrolimus Capsules 5 mg | Alu-Alu blister 10×10 in mono-carton with leaflet |
| Prolonged-release | Confirm pack configuration only if this SKU is manufactured and approved |
Alu-Alu is specified rather than offered as an upgrade.
Tacrolimus capsules are moisture sensitive, and the amorphous solid dispersion that gives the product its dissolution behaviour is the element at risk if moisture ingress occurs over a 24-month shelf life in Zone IVb conditions.
Strength differentiation in print and colour is also a safety-relevant design requirement, since patients commonly hold two or three strengths at once during titration.
Why Source Tacrolimus Capsules From Us?
NTI-Grade Bioequivalence Package: We state which authority’s tightened acceptance criteria our BE study was designed and powered against, rather than claiming BE data generically.
On a narrow therapeutic index medicine that distinction decides whether your submission succeeds.
Contained Manufacturing for a Potent Immunosuppressant: Segregated block with dedicated air handling, HBEL-based cleaning validation and documented operator protection.
GMP certificate and Site Master File (SMF) shared on request.
Solid-State Control Across Shelf Life: Amorphous form stability is verified by solid-state characterisation in the stability programme, not assumed from assay and dissolution.
Recrystallisation on an NTI drug changes exposure, and we test for it.
Low-Dose Uniformity Assurance: At 0.5 mg, content uniformity is the governing risk. We demonstrate it at batch level, with data supplied on request.
Complete Dossier for 100+ Countries: CTD, ACTD and eCTD dossiers pre-compiled, with regulatory query response support included.
Supply Continuity Built for Maintenance Therapy: Transplant patients remain on immunosuppression indefinitely. We schedule contained-block campaigns against committed forecasts so continuity is engineered, not hoped for.
Frequently Asked Questions
Q1. Do you provide a dossier for Tacrolimus Capsules?
Yes. We provide complete dossiers in CTD, ACTD and eCTD formats for Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg. The dossier includes Module 3 quality documentation, solid dispersion process validation, solid-state characterisation, low-dose content uniformity data, ICH Zone IVb stability and the bioequivalence study report. Country-specific customisation and regulatory query support are included as standard.
Q2. Which bioequivalence criteria was your Tacrolimus study conducted against?
This is the right question to ask, because acceptance criteria for a narrow therapeutic index drug differ by authority. EMA applies a narrowed 90.00–111.11% interval to AUC but retains conventional limits for Cmax on this molecule; Health Canada applies 90.00–112.00% to AUC; the US FDA requires a reference-scaled approach with a fully replicated design; and some authorities apply conventional limits. Contact us with your target market and we will confirm exactly which criteria our study package satisfies.
Q3. Can Tacrolimus Capsules be registered on a biowaiver?
No. Tacrolimus is BCS Class II and additionally classified as an NTI drug, so no biowaiver route exists and in-vivo bioequivalence data is mandatory. Any supplier suggesting a biowaiver for this molecule has misunderstood the regulatory position, and it is worth treating that as a signal about the rest of their dossier.
Q4. How do you control the amorphous form in the capsule?
Tacrolimus is poorly soluble and formulated as a solid dispersion, so the amorphous state is generated in-process and cannot be corrected downstream. We control it through defined process parameters during manufacture and verify it through solid-state characterisation within the stability programme, confirming that no recrystallisation occurs across shelf life under ICH Zone IVb conditions.
Q5. Is your Tacrolimus manufactured in a contained facility?
Yes. Tacrolimus is produced in a segregated contained block with dedicated air handling appropriate to a potent immunosuppressant. Cleaning validation is performed against a toxicologist-authored health-based exposure limit, and containment qualification is documented in our Site Master File (SMF), which we share on an NDA basis during technical evaluation.
Q6. Can you supply Tacrolimus Capsules under our private label?
Yes, with two firm limits. Safety labelling including the boxed warning, specialist prescriber statement and interaction cautions is fixed regulatory content. And strength differentiation in capsule print and carton design is a patient-safety feature, because patients hold multiple strengths during titration, so a uniform look across strengths cannot be accommodated.
Q7. What is the MOQ and lead time for Tacrolimus Capsules?
MOQ varies by strength and pack configuration, and the three strengths are normally quoted as a titration set rather than individually. Because production runs in scheduled campaigns within a contained block, lead time is driven by campaign planning. Please contact our export team with your target market and annual forecast for MOQ, lead time and a tailored quotation.
Q8. Which countries do you export Tacrolimus Capsules to?
We supply markets with established transplant programmes across Southeast Asia (Philippines, Vietnam, Indonesia), the Middle East and North Africa (Iraq, Jordan, Egypt), Latin America (Colombia, Peru, Ecuador) and the CIS (Uzbekistan, Kazakhstan). Registration support is provided per market, and we also confirm therapeutic drug monitoring capability, since the product cannot be used safely without it.
Call to Action
Ready to Source Tacrolimus Capsules FDF?
Tell us which market you are registering in and we will confirm which bioequivalence criteria apply there, what our study package satisfies, and the dossier format, pack options and campaign lead time.
If you are at technical evaluation stage, request the BE study abstract, solid-state stability summary, containment section of the SMF and a sample CoA.