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99% Cyclosporine API Of GMP Factory In China

Why You Import Cyclosporine API From Us?

#1. GMP/FDA/WC approved:

Our Cyclosporin A is approved by China SFDA and US FDA, and the whole set of registration docs is ready.

WC is also available in 2024

#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 repacking for 100G, 50G 10G, or less.

Looking For the largest Cyclosporine GMP Manufacturer In China? Contact Us Now!

Cyclosporine Specifications

99% Cyclosporine GMP API With Best Prices
Cyclosporin A Chemical Structure

Introductions:

Cyclosporine, marketed under the brand name Atopica or Optimmune, is an immunosuppressant mainly used for patients with transplants.

It is also used in vet clinics for dogs and cats to treat atopic dermatitis.

Cyclosporine 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. 

Product Name: Cyclosporine (环孢素A, 环孢霉素,Ciclosporin, Cyclosporin A, Cyclosporine 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 be shipped by air as common goods.

Grade: Pharmaceutical Grade

Purity or Assay: 99%

Standards: Current USP Standards

Manufacturer Certificates available: Local GMP/WC/CoPP/Drug Manufacturing License/ISO

Manufacturer Documents Available: COA/MSDS/Stability Data Sheet/DGM Certificate

Supply Capability: 500KG~1000KG per month

MOQ: 100G

Raw Material Price Ideas In 2023: 3000~4000 USD/KG for quantities less than 1 KG, 1850~1900 USD/KG for several Kilo Grams, and about 1550 USD/KG for order quantities over 50 KG. (Please contact us by WhatsApp for more updated prices)

Lead Time: 5~7 days for quantities less than 50KG, 3~4 days for orders less than 5KG.

Stock Status: Over 100KG

Shipping Temperature: Room temperature

Long-Term Storage: 2~8 °C

Technical Data: 

Loss on drying: NMT2.0%

Heavy metals: NMT20ppm

Related substances: Individual impurity: NMT0.7%, Total impurities: NMT1.5%, Other unknown impurity: NMT0.1%

Residual solvents: Ethanol: NMT5000ppm, Acetone: NMT5000ppm, Ethyl acetate: NMT5000ppm

Microbial limits: TAMC: NMT1000cfu/g, TYMC: NMT100cuf/g

Assay: 97.0%~101.5%

Why Choose Us As Your Cyclosporine Supplier In China?

You are in the right place if you are looking for 99% type Cyclosporine API with GMP/DMF for your compounding pharmacies or medicine manufacturing factories. Below are why you should select OCTAGONCHEM as your cyclosporine manufacturer in China.

#1. Your steady supply chain for pharma-grade APIs

OCTAGONCHEM is the cyclosporine supplier that supplies cyclosporine API with GMP/DMF/WC/COPP and a yearly production capacity of over 3000 KG, it is suitable for pharmacy compounding and capsule manufacturing in many countries.

#2. APIs with GMP quality assurance

Our cyclosporine factory is certified with Chinese GMP, ISO9001, and EHS, meanwhile, our cyclosporine is registered in the USFDA and approved with COPP, and registered in Europe and approved with WC certificate, which means, the importers from North America and Europe are free to import our Cyclosporine API into their own countries.

#3. Decades of good reputations to uphold

As a cyclosporine supplier in China for over 10 years, we have exported cyclosporine API to many countries such as the USA, Italy, Australia, Colombia, Ecuador, etc. We received nothing but compliments on our quality. There is zero complaint rate so far, and we are proud of it.

Feel free to contact us for a quote and compare what we can offer for you.

Frequently Asked Questions By Importers

Q1. We are a compounding pharmacy located in Europe, is your cyclosporine API suitable for pharmacy compounding?

A1. Yes, it is. 

In China, we hold a Drug Manufacturing License for it, which is already made into medicines by many of our domestic medicine manufacturers. Its dosage forms include capsules, tablets, solutions, etc.

Internationally, we have the CoPP issued by the USFDA and Written Confirmation issued by EU Authorities for our cyclosporine API, and several world-famous pharmaceutical companies are using our cyclosporine for their medicine manufacturing too, so there is no doubt that our cyclosporine raw materials can be legally used 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 for our cyclosporine API is over 98.0% by HPLC, though the requirement of Assay in USP is 97.0%, the actual value of our cyclosporine is 99.0% or higher.

As for the control over impurities, we keep the total impurities below 1.5% and the single impurity below 0.7%. For other unknown single impurities, it is controlled at less than 0.1%.

The main impurities are as below:

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 and its RT is about 1.35, its quantity is around 0.3%

2.3 Cyclosporine D: 

also produced in the fermentation process with a retention time of 1.44 and 0.2% quantity.

Q3. Do you provide a sample free of charge before our formal order, say 1~5 Grams?

A3. Yes, we can provide the sample for your quality approval, on the basis that you have already agreed to our price offer.

We need to do the repacking for the samples to be tested, so you must provide your courier account for the freight to collect.

Q4. How soon can you ship my order for non-standard packings, say 0.5KG, 1KG, or 5KG?

A4. Due to our steady supply management, we keep a running stock of over 50 KG and we can do the repacking within 2 days after your order confirmation, so the soonest tracking information will be provided to you on the 3rd day, which is 3 days in total.

Q5. Do you provide Customs Clearance Services in destination countries? We only want to make the payment when the goods are delivered to our warehouses.

A5. For customers who need to order against the terms of DDP, we do have agents who provide this service, but only in several countries, such as the USA, UK, Germany, and France.

For almost 90% of our shipments, the import clearances are handled by importers because importers 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 give us the residual solvents details?

A6. Yes, please check the solvents used during the production process below:

6.1 Ethanol

Ethanol is the solvent used for cyclosporine extractions. However, no ethanol is found in the purified cyclosporine, so we don’t impose a limit on ethanol.

6.2 Ethyl acetate

Ethyl acetate is the solvent for extraction and chromatography processes. We impose a limit of 0.5% or 5000ppm, its testing value is below testing limits.

6.3 Acetone

Acetone is used during the process of concentration, chromatography, and crystallization process. Its limit is 5000ppm, and the content is around 2000ppm.

Q7. Do you accept PayPal and credit cards for payment except international wire transfers?

A7. Yes, we do. You can pay by PayPal to our PayPal account, but the transactions from PayPal are incredibly high for options of payment for goods. For amounts over 1000 USD, it is better to pay by wire transfer.

As for the payment by credit card, it is just a variation for international transfer through wise.com. If you are not clear on how to do it, contact us directly.

Q8. Is the pharma-grade cyclosporine API stable if you ship it without adding ice bags to keep it cool?

A8. Yes, cyclosporine API is a very stable raw material, and we have done the stability test for it. It is stable for 3 years when stored at room temperature.

As we all know when we ship goods by air, the cargo section is very cool if not cold. Thus the temperature during air transportation will not harm its purity.

Manufacturer Documents Download

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