How To Import Cyclosporine API Powder From China?
Cyclosporine API， also known as Ciclosporin, is one of the most important pharmaceutical ingredients exported from China every year due to the uprising demand.
It is widely used as an immunosuppressant for transplants.
Meanwhile, it is also used as an intermediate further made into advanced active molecules for certain rare diseases.
Many veterinary clinics are using compounding cyclosporine dosages to cure our furry friends.
Speaking of how to import cyclosporine API from China, there are mainly 5 factors to be made clear before your import:
#1. What is the current price of cyclosporine API, and do I have enough funds to import it?
#2. Who is currently importing cyclosporine API from China, and who is manufacturing and supplying it?
#3. The HS Code of Cyclosporine API to know the import duties and fees.
#4. What import permits are needed to import Cyclosporine API to the country of destination?
#5. How to Ship Cyclosporine and what is the related shipping cost?
After you have all the information on all the 5 issues above, you are ready to go.
Now let’s go through these 5 issues one by one!
#1. How Much Does Cyclosporine API Cost In 2023?
For any import, you must get yourself reasonable prices from reliable suppliers first, which means you will need to do a lot of sourcing and comparing the offers, especially when your budget is limited.
You need to be clear about your budget, the calculations on how much you can spend, and what quantity you can get.
Of course, different suppliers have different prices, we just give you a general export price idea for your reference.
For commercial order quantities of 50kg or more, with GMP&FDA approval, the market price from China is about 1550 USD/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 100~500 Grams, the cost is about 3~4usd/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 has been no stock in China for a while from GMP factories due to the shortage of starting raw materials.
Only after the middle of 2022 and the stock is back again.
You can also check its India export prices listed on pharmacompass 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.
Below is the prices from some reagent companies you may want to look into:
As we can see above that the prices from reagent companies are extremely high, not competitive at all.
Sure they have discounts for many research institutions due to their long-term business relationships. and they provide supreme after-sale services.
Either way, it is up to you where to buy it, all depending on your needs.
If you need the chemical urgently, you go to the reagent companies.
If your project is not that urgent, you have plenty of other choices.
If your quantities are over kilos, just forget the reagent companies.
#2. Who Is Importing Cyclosporine API From China?
#1. Current foreign importers of Cyclosporine API include:
#2.1 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.
#2.2 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.
#2.3 Research institutions
If you are a researcher and you need it for research, you can check prices from local reagent companies listed 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.
#2.4 International distributors and traders, agents
All those first 3 types of importers are end users, but that doesn’t mean we don’t work with distributors or agents. We have many distributors and agents abroad.
Not all end users are familiar with the import procedures, and neither do they want to go the extra mile to import small-quantity chemicals by themselves, so they would rather go to the local suppliers and distributors who are very experienced and professional in API import for help, thus, there won’t be any customs issues for them.
Plus, trading companies are willing to sell quantities less than the Minimum Order Quantity set by exporters by repacking standard packages into smaller packings.
The thing is, if your order quantity is too small, it is not worth the shipping and handling cost, and you even have better prices from your local suppliers and distributors.
#3. Current suppliers and manufacturers of Cyclosporine API with GMP in China
#3.1. NCPC Huasheng Pharmaceutical Co., Ltd
NCPC Huasheng is one of the largest manufacturers of cyclosporine API in China.
Almost half of their cyclosporine is exported to foreign countries, and the other half is made into medicines for Chinese domestic markets.
Octagonchem is one of the designated distributors and suppliers of NCPC’s cyclosporine API.
#3.2. Zhejiang Ruibang Laboratories
Ruibang is the second largest cyclosporine API manufacturer in China.
They also have their finished formulations of cyclosporine capsules manufactured for Chinese domestic markets, other unused cyclosporine raw materials will be exported for importers in other countries.
#3.3. Huadong Medicine Co., Ltd
Huadong Medicine, also known as East China Pharm, is the third largest cyclosporine raw material manufacturer.
Their APIs are mainly for the high-end markets, such as medicine manufacturers in the USA and Canada, so their export prices are not quite competitive.
Other suppliers in China include Joyong lab, Fujian Kerui Pharma, Guangdong Taisende, etc.
Besides suppliers in China, there are also foreign suppliers out of China for it, these competitors include:
1. TEVA CZECH INDUSTRIES S.R.O. Opava CZ
2. AbbVie Inc. North Chicago US
3. Apotex Fermentation Inc. Winnipeg CA
4. CKD BIO CORPORATION Ansan-si KR
5. CURIA ITALY S.R.L. Rozzano, Milano IT
6. CONCORD BIOTECH LIMITED Ahmedabad IN
The suppliers mentioned above are pretty much all the players in the market for cyclosporine.
If you need to get the best prices for your import, all you need to do is contact them one by one for a quotation. Get the best offer and make a purchase.
#4. What Is HS Code Of Cyclosporine?
HS Code is something that categorizes the goods through Customs into certain categories so Customs can better regulate the import and export.
Through this code, you will know your import tax rate, and whether there are Mandatory Customs regulations on commodity inspections or not, etc.
However different countries have different HS Codes due to different categorizing methods while sharing some similarities.
If you are not sure, consult your import broker to be safe.
#4.1 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.
However 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 the 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.
#4.2 HS Code As Finished Formulations (Extra Knowledge for Free)
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).
#5. What import permits are needed to import Cyclosporine API?
No matter which country the importer is located in, pharmaceutical products are the most complicated issue to handle.
Almost 99% of the pharmaceutical products imported are regulated by your FDA, which means you will require authorizations or import permits to import them.
This import permit is the most important thing, without it, your goods will rot in your Customs and you have to pay for the fees to destroy them too.
Take Egypt for example, say a medicine manufacturer needs to import Cyclosporine API for medicine manufacturing in Egypt.
If the medicine manufacturer plans to import cyclosporine API into the USA, the importer has to apply for an import permit from the Egyptian Ministry of Health first.
The docs needed to apply for an import permit, are as below:
1. GMP (CoPP/CEP/WC/TGA etc, as long as it is proved for import in developed countries, it is all fine)
2. DMF (open and closed part)
After the docs required for the import permits are approved, the importer will get the permit from the MOH, so the clearance won’t be a problem in Egyptian Customs.
It is similar for importers in other countries, say the USA.
The pharmaceutical manufacturer has to be registered with the USFDA to get a CDN number for any pharmaceutical products imported in commercial quantities.
Plus, to submit DMF, later to get CoPP, which equals to GMP certificate for certain APIs.
With all that said, you need to make sure that you have the permits to import this API.
For research scholars, it should be easier than human-use medicines.
For example, some universities have an import permit to import a certain amount of APIs and reagents by a wide range.
Once the chemicals or reagents are in Customs, show the import permits to FedEx and FedEx staff will help with the clearance, they can even do pre-clearance to speed up the clearance.
#6. What Is The Shipping Cost Of Cyclosporine By Air?
Once you have worked out the import permits, and found the right cyclosporine supplier for your order, now it is time to consider the shipping methods.
As cyclosporine is not cheap, the commercial order quantity of over 200kg will be a heavy customer.
This leaves you almost one option: to ship it by air/courier.
The general shipping cost per KG for over 100 KG is about 15~20 USD per KG, depending on the country of destination.
If it is far from China, or the country is at war, or under sanctions, the shipping costs will be higher.
Shipping cost to the USA for 100 KG is around 17 USD/kg, and to Europe is about 19 USD/kg.
If you only order 1kg or less and you still need it to be shipped to your airport, the shipping cost is about 500~700 USD 1 KG is not worth the shipping cost at all.
If you can accept shipping by FedEx, the starting 500G is around 60~70 USD, and to Europe is around 70~80 USD.
To conclude the whole process:
First, you know all the costs related to the import, then you know the import regulations, and you are ready to go.
And we think it is pretty much everything you need to know about how to import Cyclosporine from China to your country.
In case you have anything unclear, or you have different opinions or better ideas, welcome to comment below or contact us directly.