99% Cyclosporine Powder Of GMP Manufacturer
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Why You Should Import Cyclosporine Powder From Us?
#1. GMP/FDA approved:
Our Cyclosporin A is approved by China SFDA and US FDA, and the whole sets of registration docs are ready.
WC is also available currently.
#2. Quality guarantee:
For any quality issues, you will get an exchange of goods for free or you can receive a full refund.
#3. Low MOQ:
Our minimum order quantity starts at 1KG for trial 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: Updated HS code as 2941909099, other antibiotics-其它抗菌素
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, and slightly soluble in water.
It is one of our GMP Approved APIs along with tacrolimus powder and sirolimus (Rapamycin).
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 tabs or caps for patients with organ transplants, as they 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, and nephrotic syndrome.
Cyclosporine is also made into eye drops to relieve the symptoms of dry eyes.
How Is Cyclosporine Powder Manufactured?
1. Fermentation
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, and 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.
2. Separation
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?
Cyclosporine is an immunosuppressive medication that is used to prevent the rejection of transplanted organs and to treat certain autoimmune and inflammatory disorders.
It is available in the form of a capsule or solution and is taken orally or injected intravenously.
1. Immunosuppressive agents
One of the main uses of cyclosporine is to prevent organ transplant rejection.
After a transplant, the body’s immune system may recognize the transplanted organ as foreign and try to attack it.
Cyclosporine helps to suppress the immune system and reduce the risk of transplant rejection.
It is often used in combination with other immunosuppressive medications to provide maximal protection against rejection.
Clinically cyclosporine is mainly used as an immunosuppressive agent for patients with transplants.
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 reactions in bone marrow transplantation.
2. Treatment of Immune diseases
It is also used together with adrenocorticotropic hormone for the treatment of some immune diseases.
Cyclosporine is also used to treat certain autoimmune and inflammatory disorders, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.
These conditions are characterized by chronic inflammation and overactive immune responses, and cyclosporine helps to suppress the immune system and reduce inflammation.
3. Off-Label Uses
in recent years, it has been reported to be used in the treatment of uveitis, heavy aplastic anemia, refractory autoimmune thrombocytopenic purpura, psoriasis, refractory lupus nephritis, etc.
In addition to these uses, it is sometimes used off-label to treat other autoimmune and inflammatory disorders, such as multiple sclerosis and lupus.
However, it is important to note that the safety and effectiveness of cyclosporine for these conditions have not been fully established and more research is needed.
It is crucial to use cyclosporine as directed by a healthcare provider.
The dosage and duration of treatment will depend on the specific condition being treated and the individual patient’s response to the medication.
Cyclosporine can cause serious side effects, including an increased risk of infection and cancer, and it should be used with caution in certain populations, such as the elderly and those with kidney or liver problems.
In conclusion, cyclosporine is an immunosuppressive medication that is used to prevent organ transplant rejection and to treat certain autoimmune and inflammatory disorders, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.
It may also be used off-label to treat other autoimmune and inflammatory disorders, but more research is needed to fully establish its safety and effectiveness for these uses.
It is important to use it as directed by a healthcare provider and to be aware of the potential risks and side effects of the medication.
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 nor explosive in any way.
Its flash point is 736.3°C and its boiling point is 1293.8°C.
It is relatively stable for heat.
For more safety details, you can check its MSDS data below in the download section.
#2. Side effects as a drug:
1. Nephrotoxicity:
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 you are recommended to insist on regular follow-up visits during the medication period and do blood routine and liver and kidney function checks.
2. Hypertension:
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 possibility 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 the immunosuppressive drugs, the patients may experience obesity after taking it.
This is mainly because 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 medications.
Cyclosporine vs Tacrolimus
Cyclosporine and tacrolimus are both immunosuppressive medications that are used to prevent organ transplant rejection and treat certain autoimmune and inflammatory disorders.
They work by inhibiting the activity of certain immune cells and reducing inflammation, but they differ in some key ways.
#1. Usages
In terms of their uses, cyclosporine, and tacrolimus are both used to prevent organ transplant rejection and to treat certain autoimmune and inflammatory disorders, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.
However, tacrolimus is more commonly used to treat skin conditions, such as atopic dermatitis and poison ivy, while cyclosporine is more commonly used to treat kidney transplant rejection and certain types of lymphoma.
Cyclosporine was discovered in 1971 and approved as an immunosuppressant drug for organ transplant rejection.
Tacrolimus was not discovered till the 1980s and was not approved as a drug for transplant rejections until 1989.
#2. Metabolism
One of the main differences between cyclosporine and tacrolimus is the way they are metabolized in the body.
Studies conducted by Nephrology Department, Hospital de Santo António, Porto, Portugal have shown that tacrolimus is less nephrotoxic.
Cyclosporine is metabolized in the liver and is primarily excreted through the kidneys, while tacrolimus is metabolized in the liver and small intestine and is primarily excreted through the feces.
This can affect the way these medications are dosed and monitored in patients.
That’s why tacrolimus showed easier blood pressure control but a higher chance of causing diabetes.
#3. Popularity
Studies have shown that tacrolimus is superior in 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. Side Effects
Another difference between cyclosporine and tacrolimus is their side effect profiles.
Both medications can cause serious side effects, including an increased risk of infection and cancer, but they can also cause different specific side effects.
Cyclosporine can cause kidney damage, high blood pressure, and tremors, while tacrolimus can cause nerve damage, tremors, and skin discoloration.
#5. 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 the GRAM, one is sold by KG. Tacrolimus is just more expensive in terms of unit price.
In conclusion, they differ in the way they are metabolized in the body and their specific side effect profiles, and they are used for different specific indications.
It is important to use these medications as directed by a healthcare provider and to be aware of the potential risks and side effects.
What Is Cyclosporine's HS Code?
#1. HS Code As an API
Its pure powder is an organic compound and a cyclic peptide with eleven amino acids.
Though it is an immunosuppressant, it is classified as one group of chemical compounds called other antibiotics with HS code 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 about it.
Once we declare our Propylthiouracil powder as 2942000000 (the correct hs code for propylthiouracil should be 2933599099.
Our goods are rejected by our customs for false HS declaration once.
Later we had to declare it again to get it released from Shanghai airport.
But some websites are claiming that the latest HS Code for cyclosporine 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)
However, there are also websites considering its HS Code as 2941909099, which is THE OTHER ANTIBIOTICS.(其他抗菌素)
The latest update on the correct HS code by end of March 2023 is 2941909099, please note.
Ensure your import broker gets it straight before your import so that you can avoid possible delays in Customs Clearance.
#2. HS Code As 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 2022?
For commercial order quantities with GMP&FDA approval, the 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.
If you only order 100~500Grams, the cost is about 5~7usd/Gram including shipping cost by FedEx.
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 a 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 at such a low price.
Who Should Buy Cyclosporine Powder From Us?
#1. Medicine or Formulation manufacturers
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 commercial manufacturing.
#2. Compounding pharmacies
If you are buying pure powder for pharmacy compounding, you are in the right place.
We have happy pharmacy owners using our materials for years.
We can do the repacking for order quantities less than our GMP standard packing.
If you contact the GMP factory directly, it won’t be that easy for them to say yes to 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, and 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 our best to deliver the first-tier goods at 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 on bred dogs unless a veterinarian thinks that the risk-benefit ratio is justified.
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 in your dogs, and you find the top brands are too expensive, you should find a local Vet clinic for dosage compoundings to lower your cost.
What is even better is: if your vet does not have the raw materials at good prices, 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 are your best choice.
For your urgent orders, it is recommended to ship them by direct flight to your airport 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 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 the 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 an ice pad to keep it cool because the powder is stable at room temperatures.
#2. Storage
As for storage, it should be stored in a dry and secure place with an inner package sealed well.
It should be protected from light and heat.
Also, make sure the storage temperature is 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
References
- https://pubchem.ncbi.nlm.nih.gov/compound/5284373
- https://en.wikipedia.org/wiki/Ciclosporin
- http://www.sjkdt.org/article.asp?issn=1319-2442;year=2018;volume=29;issue=6;spage=1376;epage=1385;aulast=Azarfar
- https://www.ncbi.nlm.nih.gov/pubmed/15194300
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4548586/
