99% Tacrolimus API Of GMP Factory
Tacrolimus (also known as FK-506 or fujimycin) is a 23-membered macrolide lactone immunosuppressant discovered in 1984 from the fermentation broth of a Japanese soil sample containing the bacterium Streptomyces tsukubaensis. As a calcineurin inhibitor, it has fundamentally transformed transplantation medicine since its FDA approval in 1994.
Our Tacrolimus API is manufactured under strict current Good Manufacturing Practice (cGMP) conditions, meeting USP, EP, and CP pharmacopoeial standards.
Whether you’re a pharmaceutical manufacturer developing finished dosage forms for transplant protocols, a compounding pharmacy preparing patient-specific formulations, or an API buyer seeking reliable supply, we deliver consistency, traceability, and regulatory confidence with every batch.
Tacrolimus API Applications and Specifications
Manufacturer Documents Download
Organ Transplantation — The Primary Indication
Tacrolimus capsules are indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic kidney, liver, or heart transplants, in combination with other immunosuppressants. It is also FDA-approved for the prevention of rejection in lung transplant patients.
Kidney Transplantation — Tacrolimus is the preferred calcineurin inhibitor in many renal transplant protocols. Initial oral dosage for adults: 0.2 mg/kg/day with azathioprine, or 0.1 mg/kg/day with MMF/IL-2 receptor antagonist, divided in two doses every 12 hours. For pediatric patients: 0.3 mg/kg/day.
Liver Transplantation — Initial oral dosage for adults: 0.1 to 0.15 mg/kg/day with corticosteroids only, divided in two doses every 12 hours. For pediatric patients: 0.15 to 0.2 mg/kg/day.
Heart Transplantation — Initial oral dosage for adults: 0.075 mg/kg/day with azathioprine or MMF. For pediatric patients: 0.3 mg/kg/day.
Lung Transplantation — Tacrolimus reduces chronic lung allograft dysfunction (CLAD) and is now FDA-approved for lung transplant patients.
Bone Marrow Transplantation — Tacrolimus is used to prevent and treat graft-versus-host disease (GVHD). It is also used for severe refractory uveitis after bone marrow transplants.
Autoimmune and Dermatological Applications
Atopic Dermatitis (Eczema) — Tacrolimus is used in topical preparations for the treatment of atopic dermatitis.
Rheumatoid Arthritis — Tacrolimus, along with Cyclosporine, is a calcineurin inhibitor used in patients with active rheumatoid arthritis.
Other Indications — Tacrolimus is also used for exacerbations of minimal change disease and the skin condition vitiligo.
Compounding Pharmacy Applications
For compounding pharmacies, our Tacrolimus API provides the flexibility to formulate:
Oral capsules — 0.5 mg, 1 mg, and 5 mg strengths
Oral suspensions — for pediatric patients and patients with swallowing difficulties
Topical ointments — for atopic dermatitis and other dermatological conditions
Ophthalmic formulations — for ocular inflammatory diseases
Parenteral formulations — for IV administration in acute settings
Product Name: Tacrolimus APIs (他克莫司)
Cas Number: 109581-93-3 For Monohydrate (104987-11-3 For Anhydrous, which we don’t supply)
Molecular Formula: C44H69NO12*H2O
Molecular Weight: 822.03 g/mol
Chemical Name: 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-, monohydrate
HS Code: 2934999090 ((Other heterocyclic compounds-其他杂环化合物))
Suitability to be shipped by air as common goods: suitable. It is safe to be shipped by air as common goods.
Grade: Pharma-Grade
Purity or Assay: 99%
Standards: Current USP Standards
Manufacturer Certificates available: GMP/CoPP/WC
Supplier Documents Available: COA/DMF/MSDS
Supply Capability: 50+ KG per Month
MOQ: 10 Grams
Tacrolimus API Price Ideas In 2023: 30~40 USD/G for 1KG, 50~60 USD/G for 100~500G, 110~150 USD/G for 1G~10G. (For more updated prices, contact us directly by email or WhatsApp)
Lead Time: 3~5 days for quantities less than 10KG, 3~4 days for orders less than 100 G.
Stock Status: Over 50 KG
Shipping Temperature: Room temperature
Storage: 2~8 °C
Technical Data:
Residue on ignition: NMT0.1%
Heavy metals: NMT10ppm
Specific optical rotation: -110 ~ -115°
Related substances:
Ascomycin 19-Epimer: NMT0.1%, Ascomycin: NMT0.5%, Desmethyl Tacrolimus: NMT0.1%, Tacrolimus 8-epimer: NMT0.15%, Tacrolimus 8-propyl analog: NMT0.15%, Any individual unspecified impurity: NMT0.1%, Total impurities: NMT1.0%
Residual solvents: Ethanol: NMT0.5%, Acetone: NMT0.5%, Ethyl acetate: NMT0.5%, Isopropyl ether: NMT0.05%
Assay: 98.0%~102.0%
Why Choose Us As Your Tacrolimus API Supplier?
Are you still searching for a reliable manufacturer of tacrolimus API in China?
Well, search no more!
OCTAGONCHEM is the ideal match if you are seeking a Tacrolimus supplier that offers top-quality products at competitive prices. Here are reasons to select OCTAGONCHEM as your API partner in China.
#1. Unparalleled High Quality Through Optimal Manufacturing Process:
At OCTAGONCHEM, we take pride in our unwavering commitment to quality.
Our Tacrolimus API is manufactured in our GMP-approved facility using our optimized manufacturing process.
As you can see from our Certificate of Analysis, the actual impurity value is 0. Our API is GMP-certified, making it suitable for use in the manufacture of medicines once you obtain your MOH registration.
You can also import it for compounding in a pharmacy.
#2. Stable Supply By Fast Shipping and Timely Delivery:
As is well known, a stable supply is crucial for the manufacture of medicine.
You are worry-free about supply issues when you choose OCTAGONCHEM as your Tacrolimus manufacturer in China.
To ensure a stable supply for our regular customers, we will maintain approximately 25 kg in stock and ship promptly upon receipt of purchase orders.
Shipping by air requires a certificate of safe air transportation from DGM. We usually apply for each copy at the beginning of each year to ship the goods within 3 days of our customers’ order confirmation.
#3. NDC number/CoPP/WC Available For Smooth Import:
As our Tacrolimus API is registered with the USFDA and the European Commission, it is suitable for compounding pharmacies in the USA, Canada, and Europe to import our API without any Customs issues.
If you are interested, please send us our offer and CoA for your approval. Your trust and reaching out to us will mean the world to us.
Frequently Asked Questions (FAQ) – Tacrolimus API
1. What is Tacrolimus API used for?
Tacrolimus API is an immunosuppressant drug primarily used to prevent organ rejection after transplant surgeries (kidney, liver, heart). It is also used to treat atopic dermatitis and other autoimmune disorders. Tacrolimus inhibits T-cell activation and cytokine production.
2. Is your Tacrolimus API GMP certified?
Yes, our Tacrolimus API is manufactured in a WHO-GMP, ISO-certified facility that meets USP, EP, JP, and other international pharmacopeia standards. We also provide a Drug Master File (DMF) and complete regulatory documentation to support product registration and compliance.
3. What is the minimum order quantity (MOQ) for Tacrolimus API?
We offer flexible order quantities to suit different business needs. Our minimum order quantity (MOQ) typically starts at 10g, with bulk purchasing options available ranging from 1kg to 100kg. Please get in touch with our sales team for personalized pricing information.
4. What is the standard purity level of Tacrolimus API?
Our Tacrolimus API achieves a minimum potency of 98.5% (as determined by HPLC), meeting USP and EP specifications and ensuring high efficacy, stability, and safety in pharmaceutical formulations.
5. Do you provide regulatory support for global approvals?
Absolutely. We supply all essential regulatory documents, including:
Certificate of Analysis (CoA)
Drug Master File (DMF – US & EU)
CEP/WC (EMA Approval or Written Confirmation)
MSDS and Certificate of Origin
to help you meet the requirements of global drug regulatory authorities.
6. Is Tacrolimus API suitable for oral solid dosage forms (tablets/capsules)?
Yes, Tacrolimus API is widely used in the production of oral tablets and capsules, including 0.5 mg, 1 mg, and 5 mg formulations, which are prescribed for transplant patients and the treatment of autoimmune diseases.
7. Is Tacrolimus API suitable for injectable use?
Yes, Tacrolimus API can also be formulated into injectable solutions for use in critical care or for patients who are unable to take oral medication. However, its most common application remains in solid oral dosage forms.
8. Can you supply Tacrolimus API for compounding pharmacies?
Our Tacrolimus API is GMP/CEP-compliant, meets USP-grade quality standards, and is suitable for compounding, including customized dosage forms for hospitals and specialized formulations under a pharmacist’s supervision.
9. What are the storage conditions for Tacrolimus API?
Tacrolimus API should be stored in a cool, dry place (15–30°C), protected from moisture, light, and oxidation, to ensure its long-term stability. Proper storage helps maintain the product’s shelf life, which is typically 24–36 months.
10. Do you provide product samples for quality testing and evaluation purposes?
Yes, we offer paid samples. Tacrolimus is too expensive for free samples. Samples are available in small quantities for laboratory testing, formulation compatibility studies, and stability studies.
11. Do you manufacture under contract or support private labeling?
Yes. We support contract manufacturing and offer private labeling services for partners who want to develop their own branded generic or specialty products using our Tacrolimus API.
12. Is Tacrolimus API available with DMF?
Yes. We maintain an active US Drug Master File (DMF) for the Tacrolimus API, which can be shared to support marketing authorization and compliance in global markets.
13. What Countries Do You Export Tacrolimus API To?
We export Tacrolimus API to more than 10 countries worldwide, including those in North America, Europe, Asia, the Middle East, and Latin America. We ensure products meet all local regulatory and import requirements.
14. What is the typical lead time for delivery?
Standard lead times range from 3 to 6 business days after PO confirmation and documentation approval. For urgent shipments or large orders, expedited delivery options are available upon request.
15. Is there a bulk discount available for large-volume buyers?
Yes. We offer volume-based pricing and bulk discounts to our regular importers and manufacturers, tailored to your order volumes and frequency. Contact us to get a custom quotation.
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