99% Cyclosporine Powder Of GMP Factory In China
Looking For the largest GMP-Approved Cyclosporine Manufacturers In China?
Contact Us Now!
Why You Should Import Cyclosporine Powder From Us?
#1. GMP/FDA approved:
Our Cyclosporin A is approved by China SFDA and US FDA, the whole sets of registration docs are ready.
WC is also avialable currently.
#2. Quality guarantee:
For any quality issues, you will get exchange of goods for free or you can receive full refund.
#3. Low MOQ:
Our moq starts at 1KG for tial orders. For lab researchers, we can also do 100G repacking.
#4. Shorter lead time:
compared to other GMP factories, our lead time is 1~2 days shorter.
What is Cyclosporine?
Cas number: 59865-13-3
Molecular formula: C62H111N11O12
Molecular weight: 1202.6 g/mol
HS code: 2933990099
As the main-stream immunosuppressant raw material, cyclosporine is s a white to off-white crystalline solid with a very weird skunk smell.
It is soluble in acetone and methanol, slightly soluble in water.
Cyclosporine is a polypeptide with eleven amino acids, and they form a circle.
This is also where the ‘cyclo’ within cyclosporine comes from.
Some people also call it ciclosporine, cyclosporin, and cyclosporin A, actually they are the same thing.
Doctors often prescribe its tabs or caps for patients with organ transplants, as it can effectively reduce the activity of the patient’s immune system, so to lower the risks of organ rejections.
People also use it to treat rheumatoid arthritis, psoriasis, Crohn’s disease, nephrotic syndrome.
Cyclosporine is also made into eye drops to relieve the symptoms of dry eyes.
How Is Cyclosporine Powder Manufactured?
Tolypocladium inflatum Cams are used as the production strain.
Fill a 75L tank with a 50L fermentation medium, inoculated with 5×109 spores.
Adjust the PH value of medium to 5.4-4.3, and cultivate it for 72h to get the primary solution.
Fill a 750L fermentation tank with a 500L medium, seed it with the above primary solution.
Culture it for 6 days to get the secondary solution.
Fill a 4500L tank with a 3000L medium, get it fermented for 12 days, and then we get cyclosporine fermentation broth.
Add an equal volume of ethyl acetate to the fermentation broth to separate the organic layer by extraction.
We separate it by evaporating the mixture under reduced pressure, and then we get the crude product.
In the crude product, we can get cyclosporine and cyclosporine C, where the yield of cyclosporine is about 150-200mg/L cyclosporine C is about 50-100mg/L.
Those two components are further separated by HPLC.
Then the pure powder of cyclosporine is collected by crystalization.
What Is Cyclosporine Used For?
1. Immunosuppressive agents
Clinically cyclosporine is mainly used as the immunosuppressive agents for patients with transplant.
It is used to prevent the rejection of allogeneic kidney, liver, heart, bone marrow and other organs or tissues transplantation
Also it is used for the prevention and treatment of graft-versus-host reaction in bone marrow transplantation.
2. Treatment of Immune diseases
It is also used together with adrenocorticotropic hormone for the treatment of some immune diseases.
3. New explorations
in recent years, it has been reported to be used in the treatment of uveitis, heavy aplastic anemia and refractory autoimmune thrombocytopenic purpura, psoriasis, refractory lupus nephritis, etc.
Is Cyclosporine Dangerous?
#1. Safety issues as a chemical:
Chemically speaking, cyclosporine powder is tested and categorized as a very safe and common chemical to be shipped by air or by express. All the shipping companies such as FedEx, TNT, DHL and UPS are shipping it every day.
It is non poisonous and we can tell that by its LD50 of value by oral intake:
LD50 in rats by oral is 1480mg/kg
LD50 in mice by oral is 2803mg/kg
LD50 in rabbits by oral is over 1000mg/kg.
LD50 by Intravenous injection:
LD50 for rats by injection is 25mg/kg
LD50 for mice by injection is 107mg/kg
LD50 for rabbits by injection is over 10mg/kg.
It is neither flammable or explosive in any way.
Its flash point is 736.3°C and boiling point as 1293.8°C.
It is relatively stable for heat.
For more safety details, you can check its msds data below in download section.
#2. Side effects as a drug:
One of its most severe side effects is nephrotoxicity, which might be related to the susceptibility of the individual.
It may affect renal function, decrease the ability of glomerular filtration rate, and cause high urine protein, urea nitrogen, and creatinine.
However, in most cases, it is transient and will recover after the drug is reduced and stopped.
But your are recommended to insist on regular follow-up visits during the medication period and do blood routine and liver and kidney function checks.
After taking it, some patients will experience increased blood pressure and may even induce hypertension.
Therefore, for elderly patients, it is necessary to pay close attention to this adverse reaction.
If you have symptoms of high blood pressure, you need to take the medication carefully and consult your doctor immediately.
3. Cell carcinogenesis:
Like other immunosuppressants, it will greatly increase the posibility of developing lymphoma or other malignant tumors, which means it may cause cancer.
During the period of taking the medication, patients need to avoid excessive exposure to ultraviolet light to avoid malignant skin lesions and incurable skin cancer.
4. Weight gain:
As one of immunosuppressive drugs, the patients may experience obesity after taking it.
This is mainly due to the fact that these drugs are prone to water and sodium retention, and the body has symptoms of central obesity, which can be manifested as a round face and slender limbs, but the abdominal muscles are greatly increased.
5. Other side effects:
Other side effects may include increased body hair, gingival hyperplasia, paresthesia, and sometimes gastrointestinal disorders.
In severe cases, it may also cause a series of concurrent diseases such as Raynaud’s syndrome, diabetes, and pancreatitis, and the number of white blood cells in the blood may also decrease.
To conclude: it is a common and safe chemical for shipment by air, while it will cause many unwanted side effects and it is better to take extra care when you are taking its medictions.
Cyclosporine vs Tacrolimus
Those two are common drugs used for patients of transplantation to achieve adequate immunosuppression and to prevent acute rejection.
Below are their differences in details.
#1. Marketing period
Cyclosporine was discovered in 1971 and approved as immunosuppressant drugs for organ transplant rejection.
Tacrolimus was not discovered till 1980s and not approved as drug for transplant rejections untill 1989.
#2. Danger to Kidney
Studies conducted by Nephrology Department, Hospital de Santo António, Porto, Portugal has shown that tacrolimus is less nephrotoxic.
While tacrolimus showed easier blood pressure control but a higher chance to cause diabetes.
Studies have showed that tacrolimus is superior in terms of survival, graft loss, acute rejection, and steroid-resistant rejection in the first year.
Tacrolimus is the most popular for maintenance immunosuppression after liver transplantation.
#4. Raw material cost
For both those pharm-grade APIs approved by Chinese SFDA, the tacrolimus price is much higher.
The tacrolimus price of 100G is about 130usd/g, while the cyclosporine price is about 2500~3000usd/kg.
One is sold by GRAM, one is sold by KG. Tacrolimus is is just more expensive in terms of unit price.
What Is Cyclosporine's HS Code?
#1. As an API
For pure powder, it is an organic compound and a cyclic peptide with eleven amino acids.
Though it is used as an immunosuppressant, it is classified as one group of chemical compounds called other antibiotics with HS code as 2941909090 in China before Oct. 2020.
Later it was categorized for a while as other organic compounds with HS Code 2942000000.
Speaking of 29420000, please pay close attention to the HS Code starting with 2942, it is very tricky and Chinese Customs are very strict and sensitive on it.
Once we declare our Propylthiouracil powder as 2942000000 (the correct hs code for propylthiouracil should be 2933599099.
Our goods are rejected from our customs for false HS declaration once.
Later we had to declare it again to get it released from Shanghai airport.
The latest correct HS Code for pure powder is 2933990099, categorized as Other heterocyclic compounds containing only nitrogen heteroatoms. (其他仅含氮杂原子的杂环化合物)
#2. When made into Finished Formulations
If you are importing its finished formulations, its HS code should be 3004909099, which means Other medicines in prescribed doses(其他已配定剂量的药品).
How Much Does Cyclosporine Powder Cost In 2021?
For commericial order quantities with GMP&FDA approval, market price is about 1600usd/kg as cnf by air.
For small order quantities of 1kg, our cost is around 2000usd/kg as door-to-door price by express or courier.
The cost is subject to stock status and raw material price change, contact us directly for its latest quote.
Since Oct 2021, there is no stock in China for it from GMP factories due to the shortage of starting raw materials.
You can also check its India export prices listed on pharmacompass as below:
As you can see from the prices above, the average export price is 1600usd per kg, which is similar to ours.
But you know what, we can arrange fast shipment. Trust me on the lead time.
We also see the lowest offer is 1350usd per kilo, and this price is possible when old stocks need to be sold urgently.
Only in that case you would be able to get prices around 1300usd.
In other cases, watch out for quality issues by such a low price.
Who Should Buy Cyclosporine Powder From Us?
#1. Medicine or Formulation manufactuers
If you are a pharmaceutical manufacturer of finished formulations or drugs, you are in the right place.
You can produce dosage forms such as capsules or tablets with our raw materials for sure.
Our cyclosporine can meet your common needs with GMP/DMF for your MOH registration and pilot and later commerical manufacturing.
#2. Compounding pharmacies
If you are buying pure powder for pharmacy compounding, you are in the right places.
We have happy pharmacy owners using our materials for years.
We can can do the repacking for order quantites less than our GMP standard packing.
If you contact GMP factory directly, it won’t be that easy for them to say yes on the repacking.
Even if they do, you will probably get a higher price than the average offers in the market.
As we mentioned above, our cyclosporin is GMP approved, suitable for manufacturing human dosages.
Also we can make sure all the repacking and transportation are meeting GMP requirements.
#3. Research institutions
If you are a researcher and you need it for research, check those prices from famous reagent companies below.
The best price for it is from trc-Canada, 65usd/g for 5g.
Other prices from Sigma and MCE are more expensive.
For whatever reason, you can leave us a message and we will do out best to deliver the first-tier goods with reasonable prices.
You can contact us for a quote for comparison now.
Price from sigma is 310usd for 0.1g
Cost from trc-canada is 65usd/g for 5g
Unit price from mce 200usd for 0.5g
Where To Buy Cyclosporine For Dogs?
Atopic dermatitis is common in dogs and is associated with the production of IgE antibodies directed against environmental allergens.
Atopica is not recommended for use in bred dogs unless a veterinarian considers the risk-benefit ratio that is justified by the veterinarian.
Cyclosporine, marketed under the brand name Atopica or Optimmune, is an immunosuppressant commonly used in dogs and cats to treat atopic dermatitis.
It is known for its anti-inflammatory properties, but is mainly used to treat atopic dermatitis and is one of the most common types of immuno-protective agents in the United States.
If you need it to treat atopic dermatitis of your dogs, and you find the top brands are too expensive, it is better you find a local Vet clinics for dosage compoundings to lower your cost.
What is even better is: if your vet does not have the raw materials with good price, you can recommend us and we will send the samples directly to their clinics for you.
How To Ship and Store Cyclosporine Powder?
#1. Shipping methods
Cyclosporine powder is a very stable and safe chemical, not poisonous, not dangerous in any way such as flammable, explosive, oxidizing, etc.
#1.1 By air or courier for orders of small quantities.
For small orders less than 10kg, couriers is your best choice.
For your urgent orders, it is recommended to ship it by direct flight to your air port or direct express courier.
#1.2 By air for order quantity between 10~100kg
For those quantities, shipping by courier will cost more than the shipping fee by air.
So shipping by air is recommended.
#1.3. By sea for Commercial orders over 500kg.
If your order is as big as 500kg, it is recommended to ship it by sea if you want to save some money on the shipping cost.
But all in all, the most common ways are by air in our experience.
Due to its high product value, air freight cost is only a very small part of the total cost.
Say the shipping by air costs about 15usd per kilo, it is only 1/120 of product cost.
It is never wrong to ship your expensive products by air.
By the way, during the transportation there is no need to ship it with ice pad to keep it cool because the powder is stable at room temperatures.
As for storage, it should be stored in a dry and secure place with inner package sealed well.
It should be protected from light and heat.
Also make sure the storage temperature not over 25 degrees.
If you are storing a reference standard, you should put it into a refrigerator and store it under 20 degrees below 0.
Technical Documents Download