99% Cyclosporine API Of GMP Factory In China
Cyclosporine (also known as Cyclosporin A, Ciclosporin, or CsA) is a cyclic polypeptide immunosuppressant consisting of 11 amino acids. Originally derived from the soil fungus Tolypocladium inflatum Gams in 1970, this potent calcineurin inhibitor has fundamentally transformed transplantation medicine and autoimmune therapy over the past five decades.
As one of China’s leading suppliers of Cyclosporine API, we have been exporting our cyclosporine APIs to the USA, Canada, Italy, Colombia, and other countries without any quality disputes over the past decade.
Our Cyclosporine raw material is manufactured under strict current Good Manufacturing Practice (cGMP) conditions, meeting USP, EP, CP, and IP 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.
Why Import Cyclosporine API From Us?
#1. cGMP/USFDA/CEP Approved:
Our Cyclosporin A API has GMP approval from the China SFDA (NMPA), EMA, and the USFDA, and the entire set of registration documents is ready for MOH registration in other countries.
Meanwhile, the Written Confirmation (WC) will also be available in 2024.
#2. Quality Guarantee:
You can exchange the goods for free or receive a full refund if there are any quality issues.
#3. Low MOQ:
Our minimum order quantity for trial orders is 1 kg. For lab researchers and compounding pharmacies, we can also repackage in quantities of 500g, 100g, etc.
Cyclosporine API Applications and Specifications
Manufacturer Documents Download
Organ Transplantation — The Primary Indication
Cyclosporine is indicated for the prophylaxis of organ rejection in allogeneic kidney, liver, and heart transplants. In animal models, it has prolonged survival of allogeneic transplants involving skin, heart, kidney, pancreas, bone marrow, small intestine, and lung.
Kidney Transplantation — Cyclosporine is a cornerstone immunosuppressant in renal transplant protocols, always used in combination with corticosteroids.
Liver Transplantation — Cyclosporine is indicated for the prevention of organ rejection in liver allograft recipients.
Heart Transplantation — Cyclosporine forms part of the standard immunosuppressive regimen for cardiac transplant patients.
Bone Marrow Transplantation — Cyclosporine is used to prevent and treat graft-versus-host disease (GVHD).
The use of Cyclosporine to prevent rejection and GVHD has enabled successful transplantation of solid organs and bone marrow in humans.
Autoimmune Diseases
Cyclosporine has demonstrated therapeutic effects across a wide range of autoimmune conditions:
Rheumatoid Arthritis — Cyclosporine is used to treat severe, active rheumatoid arthritis in patients who have not responded adequately to methotrexate.
Psoriasis — Indicated for severe, recalcitrant plaque psoriasis.
Atopic Dermatitis — Used for severe atopic dermatitis in adults.
Crohn’s Disease — Cyclosporine is effective for moderate-to-severe Crohn’s disease.
Nephrotic Syndrome — Used in certain forms of steroid-resistant nephrotic syndrome.
Ulcerative Colitis — Cyclosporine is indicated for severe ulcerative colitis.
Ophthalmic Applications
Cyclosporine is formulated into eye drops for the treatment of dry eye disease (keratoconjunctivitis sicca).
Compounding Pharmacy Applications
For compounding pharmacies, our Cyclosporine API provides the flexibility to formulate:
Oral capsules and solutions — for transplant and autoimmune protocols
Ophthalmic solutions — for dry eye disease and ocular inflammation
Topical formulations — for psoriasis and atopic dermatitis
Custom dosage strengths — for pediatric and geriatric patients
Parenteral formulations — for IV administration in acute settings
Product Name: Cyclosporine APIs (Ciclosporina materia prima, Cyclosporin A, Ciclosporin, 环孢素，环孢素A)
Appearance: A white powder
Cas Number: 59865-13-3
Molecular Formula: C62H111N11O12
Molecular Weight: 1202.6 g/mol
Chemical Name: (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(E,1R,2R)-1-hydroxy-2-methylhex-4-enyl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone
HS Code: 2941909099 (other antibiotics-其它抗菌素)
Suitability to be shipped by air as common goods: suitable. It is safe to ship by air as common goods. (Contact us for the DGM certificate if it is needed)
Grade: Pharmaceutical Grade
Purity or Assay: 99%
Standards: Current USP Standards
Manufacturer Certificates available: Local GMP/WC/Drug Manufacturing License/ISO
Manufacturer Documents Available: COA/MSDS/Stability Data Sheet/DGM Certificate
Supply Capability: 500KG~1000KG per month
MOQ: 100G
Cyclosporine API Price Ideas: 3000~4000 USD/KG for quantities less than 1 KG, 1850~1900 USD/KG for several kilograms, and about 1580 USD/KG for order quantities over 50 KG. (Please get in touch with us by WhatsApp for more up-to-date prices)
Lead Time: 5~7 days for quantities under 50 kg, 3~4 days for orders under 5 kg.
Stock Status: Over 100 KG
Shipping Temperature: Room temperature
Long-Term Storage: Room temperature
Why Choose Us As Your Cyclosporine Supplier In China?
You are in the right place if you are looking for a 99% type Cyclosporine API with GMP/DMF for your compounding pharmacies or pharmaceutical manufacturing facilities.
Below are the reasons why you should select OCTAGONCHEM as your cyclosporine manufacturer in China.
#1. Your steady supply chain for pharma-grade APIs with competitive prices
OCTAGONCHEM is a cyclosporine API supplier that provides GMP/DMF/WC-compliant cyclosporine API with an annual production capacity exceeding 3000 kg. It is suitable for pharmacy compounding and capsule manufacturing in many countries. As for pricing, we can’t claim to have the lowest prices in China, but we guarantee the highest quality and will deliver the best offer you can find.
#2. APIs with GMP quality assurance
Our cyclosporine factory in China is certified to Chinese GMP, ISO 9001, and EHS standards. Meanwhile, our cyclosporine is registered with the US FDA and approved with COPP. It is registered in Europe and holds a WC certificate, allowing importers from North America and Europe to import our cyclosporine API into their respective countries.
#3. Decades of good reputation to uphold
We have been a supplier of cyclosporine APIs in China for over 10 years and have exported them to numerous countries, including the USA, Italy, Australia, Colombia, and Ecuador. We have received nothing but compliments on our quality, with zero complaints. We are proud of this.
Feel free to contact us for a quote and compare what we offer.
Frequently Asked Questions Of Cyclosporine API By Importers
Q1. We are a compounding pharmacy located in Europe. Is your cyclosporine API suitable for compounding in a pharmacy?
A1. Yes, it is.
We hold a drug manufacturing license in the People’s Republic of China. Many of our domestic medicine manufacturers have already developed medicines. Its dosage forms include capsules, tablets, solutions, etc.
Internationally, we have the CoPP issued by the US FDA and the CEP issued by the EMA for our Cyclosporine pharmaceutical raw materials. Several world-famous pharmaceutical companies also use our cyclosporine API for their medicine manufacturing, so there is no doubt that you can legally use our raw materials in your pharmacy for compounding.
Q2. How pure are your Pharma-Grade Cyclosporin A raw materials, and do you have any control over the related impurities?
A2. The purity of our Cyclosporin A API exceeds 98.0% by HPLC, although the USP requirement for Assay is 97.0%, and our actual cyclosporine purity is 99.0% or higher.
For impurity control, we maintain a total impurity content of less than 1.5%, a single impurity content of less than 0.7%, and other unknown single impurities at levels of less than 0.1%.
The main impurities are as follows:
2.1 Dihydrocyclosporine A:
Produced during the fermentation process, and the Retention Time is around 1.25; its quantity is about 0.3%.
2.2 Cyclosporine V:
Produced during the fermentation process, and its RT is about 1.35; its quantity is around 0.3%
2.3 Cyclosporine D:
Also produced during the fermentation process, with a retention time of 1.44 and a quantity of 0.2%.
Q3. Do you provide a sample free of charge before our formal order, say 1~5 Grams?
A3. Yes, we can provide the cyclosporine sample free of charge for your quality approval, provided you have already agreed to our price offer for a firm order. Since we need to repack the samples for testing in the same batch, please provide your courier account details (FedEx or DHL) for freight collection.
Q4. How soon can you ship my order for non-standard packaging, such as 0.5 kg, 1 kg, or 5 kg?
A4. With our steady supply management, we maintain a stock of over 50 kg and can repackage within 2 days of receiving your order confirmation. Therefore, you will receive the latest tracking information on the third day, which is 3 days after the initial shipment.
Q5. Do you provide Customs Clearance Services in destination countries? We only want to pay when the goods are in our warehouses.
A5. We have agents who provide this service for customers who need to order under DDP terms, but only in a few countries, such as the USA, the UK, Germany, and France.
For almost 90% of our shipments, importers handle the import clearances because they are more familiar with the import regulations for pharmaceutical raw materials in their own country.
Q6. We are very concerned about the solvents used during the whole manufacturing process. Can you provide details on the residual solvents?
A6. Yes, please check the solvents used during the production process below:
6.1 Ethanol
Ethanol is the solvent used for cyclosporine extractions. However, the residual solvents test shows no ethanol in the purified cyclosporine, so we don’t impose a limit on ethanol.
6.2 Ethyl acetate
Ethyl acetate is a solvent used in extraction and chromatography processes. We impose a 0.5% (5,000 ppm) limit; the test value is below it.
6.3 Acetone
We use acetone during concentration, chromatography, and crystallization. Its limit is 5,000 ppm, and its testing result is around 2,000 ppm.
Q7. Do you accept PayPal and credit cards for payment, besides international wire transfers?
A7. No, currently we only accept wire transfer or LC/DA/DP; either way, only transactions between banks.
You can pay via PayPal to our account, but the transaction fees are pretty high. For amounts over 1000 USD, it is better to pay by wire transfer.
Credit card payments are just a variation of international transfers through Wise.com. If you are unsure about how to proceed, please get in touch with us directly.
Q8. Is the pharma-grade cyclosporine API stable if shipped without ice bags?
A8. Yes, cyclosporine API is a very stable raw material. We have tested it, and it is stable for three years when stored at room temperature. As we all know, when shipping goods by air, the cargo section is typically very cool, if not cold. Thus, the temperature during air transport does not harm the purity of the goods.
Q9. If we regularly import 50 kg of Cyclosporine API per year but place orders of 10 kg each, can we sign a long-term contract to maintain stable pricing?
A9. Yes, we can. You must make a symbolic deposit after signing our contract to secure your buying prices, which will remain stable and will not be subject to periodic increases. We will prioritize fulfilling your future orders.
Finally, this deposit will be considered as the advance payment for your previous order.
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