99% Tacrolimus Powder Of GMP Factory
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Why You Should Buy Tacrolimus Powder From Us?
#1. Docs for Registration available:
FDA/GMP approval is available with the whole set of MOH registration docs ready.
#2. High quality:
Our pure powder is suitable for medicine manufacturing after registration.
It strictly meets the requirements of USP monographs.
#3. Fast shipping:
Goods can be shipped out within 3~4 days after your order confirmation.
#4. NDC number/CoPP/WC available:
It is suitable for compounding pharmacies within the USA, Canada, and Europe.
What Is Tacrolimus Powder?
Cas number: 104987-11-3
Molecular formula: C44H69NO12
Molecular weight: 804 g/mol
Tacrolimus, also known as FK-506, is a white crystalline powder.
Existing as an anhydrous or monohydrate form, it is soluble in many solvents such as ethanol, methanol, acetone, and chloroform but insoluble in water.
It was first extracted as an antibiotic from soil actinomycetes in Japan in 1984.
Later, tacrolimus is found to be very effective in reducing the activity of the patient’s immune system and the risk of organ rejection after an organ transplant.
It is one of the most effective immunosuppressants along with Cyclosporin A.
Pharmaceutical manufacturers have made it into many dosage forms.
You can even get its ointments and creams from a compounding pharmacy.
Its common dosage forms include capsules, injections, eye ointments, solutions, creams, lotions, etc.
If you are the dosage manufacturer of those dosages above, contact us now for a free quote.
We have been supplying it to many brand manufacturers over the past 3 years, our quality has been very consistent and appraised by current customers.
Wha Is Tacrolimus Used For?
Tacrolimus is widely used in the treatment of autoimmune diseases such as atopic dermatitis, allergic contact dermatitis, psoriasis, lupus erythematosus, lichen planus, vitiligo, Nethenton syndrome, and host suppression diseases.
It is currently used clinically to prevent graft rejection after liver or kidney transplantation and to treat graft rejection after liver, pancreas, kidney, heart, lung, and other solid organ transplantation that cannot be controlled with other immunosuppressive drugs.
However, due to its low level of fermentation yield and high production cost, many organ transplant patients cannot afford it financially, which has greatly limited its application in many countries.
How Is Tacrolimus Powder Produced?
Tacrolimus powder is manufactured commercially through fermentation, extraction, and purification.
The production procedure is as below:
Streptomyces was inoculated in a slant medium and incubated at 26°C for 15 days
The mature slant was selected for inoculation in a seed medium and incubated for 50 h at 26°C at 300 rpm on a shaker.
A 2% inoculum was added to the fermentation medium and placed in a fermentation tank.
The fermentation tank was placed at 26°C for fermentation.
Methanol and sodium chloride solution was added again when the fermentation proceeded to 30 hours and again when the fermentation proceeded to 50 hours.
The amount of methanol to be added was 0.01% of the volume of the fermentation broth, while the amount of sodium chloride solution to be added was 0.05 % of the volume of the fermentation broth.
The concentration of the sodium chloride solution was 1.0mol/L and the NaCl solution will not be replenished until the fermentation was carried out for 80H.
During the whole fermentation process, the tank pressure was kept at 0.0.1MPa, the aeration was 0.5 VVM, and the initial concentration of dissolved oxygen in the tank was 100 %.
At the same time, the dissolved oxygen concentration in the fermenter was maintained above 25% by changing the rotational speed during the fermentation.
In the end, the fermentation broth was collected by releasing the tank after 90 hours of fermentation.
#3. Extraction and Separation
The collected fermentation broth is separated and extracted to obtain tacrolimus.
Tacrolimus within the fermentation broth can be separated and extracted by recrystallization.
Although there are more details to be filled in on the manufacturing process, we just listed the simple procedure for your ref.
Tacrolimus vs Cyclosporine
Though tacrolimus is different from cyclosporine in several aspects, such as potency, safety, dosage forms, acting mechanism, and so on.
It is superior in many ways, for example:
#1. Tacrolimus is more effective than cyclosporine in preventing rejection in various organ transplants.
#2. Tacrolimus reduces acute and chronic rejection in liver and kidney transplant recipients.
#3. Patients treated with tacrolimus have lower rates of bacterial and viral infections than those treated with cyclosporine, especially because tacrolimus is more hepatophilic.
#4. Its efficacy for liver transplantation is 100 times higher than that of cyclosporine, thus greatly reducing the dose for clinical use and reducing the cost of the original treatment by 1/3 to 1/2.
#5. The combination of FK-506 and cyclosporine has a significant synergistic effect and better results.
Tacrolimus can be used not only to prevent immune reactions from occurring but also to treat immune reactions that have already occurred and autoimmune diseases.
It is an important molecule for the prevention of immune reactions in organ transplantation and the treatment of autoimmune diseases.
While, their biggest difference to us, as a chemical importer and exporter, is their prices.
If you are a regular importer for it, you know it is normally sold by the GRAM, as regular orders are in 2~300 grams, unless heavy buyers are buying it by kilos each order.
According to one study, it was able to significantly lower the rate of acute rejection compared with cyclosporine-based immunosuppression (30.7% vs 46.4%)
We have more details on the differences between tacrolimus and cyclosporine on our cyclosporine page, please click to check.
What is The HS Code Of Tacrolimus?
In Chinese Customs, its pure powder is classified as Other heterocyclic compounds with HS Code as 2934999090.
If you are importing its finished formulations from China such as capsules, ointments, the corresponding HS code is 30049099.
How Much Does Tacrolimus Powder Cost?
If you are looking for GMP-and-FDA-Approved Tacrolimus manufacturers, please check our price ideas below:
For commercial order quantities over 1kg, our price is around 60 usd/g. (used to be 90usd/g)
For trial orders of 10g, our price is around 100usd/g. (used to be 200usd/g)
If you only need several grams for research, we also have samples available for prompt shipping.
Please specify if you need GMP or not before your order. The price without GMP can be lower than our offer above.
For more accurate prices, please contact us directly.
You can also check its prices from reagent companies if you have difficulties in making your decisions.
There are other suppliers you can contact, but if you need reliable suppliers who can guarantee the quality and fast shipment, look no more.
You give us a chance to co-op, and you enjoy our second-to-none service.
We also did a video on how to lower your buying cost for tacrolimus medication, please check below.
Tacrolimus Cost Trend Since 2010
As you can see from the above price trends, its cost has dropped from its highest 100usd per gram since 2010 to less than 80usd per gram in 2020.
The price drop is mainly caused by manufacturing-capacity surplus and more foreign competition.
But a 20% drop within 10 years is acceptable for an old API.
You can also check its export price from India below for your ref.
As you can see, its export price from Europe to India is around 73~85usd per gram, which is similar to the cost of the GMP source.
With those lower prices of 55usd~61 per gram, you can only get materials from non-GMP sources, at least is the case in China.
What To Ask Before You Import Tacrolimus Powder?
#1. Whether your supplier has the technical package for your MOH registration.
Ask your supplier if they have documents first, such as Good Manufacturing Practice, Drug Master Files, Drug Manufacturing License, FDA, CEP, etc. Without those docs and proper registration papers, you will have trouble in your customs for your import.
#2. Whether your supplier can arrange safe shipping by air.
To ship chemicals by air, the exporter of chemicals must apply for a certificate of safe air transportation from relevant authorities. It is regarded as a 6.1 type of dangerous goods. You need suppliers who can handle the proper shipping by air for you.
#3. Whether your supplier has a quality guarantee.
Ask your supplier if they can guarantee their quality, whether they have a full refund or goods-exchange policies for any quality issues. You can add those refund or goods-exchange terms into the sales contract before ordering.
#4. Whether your supplier has any references from their current customers.
A good reference from their current customers will make your supplier more trustworthy.
If you have positive and satisfactory answers from your chemical suppliers, you can go ahead to order from them.
How To Ship And Store Tacrolimus Powder?
#1. How to transport It
As it is a very expensive API, even the quantity for commercial orders is in kilos, 10 kilos is a huge order already.
So there are not many shipping options left for its transport: we either ship it by air or by courier.
There is one issue with shipping chemicals by air, the shipper must apply for one copy of the certificate of safe air transportation.
Without it, the airlines or shipping companies will not ship it.
The trick with tacrolimus powder is that it is tested as a 6.1 type dangerous chemical in some cities, where you can only ship it by air through airlines for hazardous goods.
No courier is shipping dangerous chemicals on China’s mainland.
As for the shipping temperature, it is recommended to be shipped at 2~8 degrees celsius.
Though we have shipped samples by normal temperature to some customers and later testing shows quality does not tamper anyway.
Still, we recommend shipping at low temperatures.
#2. How To Store It
For long-term storage, it is recommended to be stored in an air-tight container, protected from light and moisture at -20 degrees celsius.
The shelf life at this temperate is 2 years as min. Just make sure to retest it before you use it.