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China wholesale Enoxaparin Api - Nadroparin Calcium – CSBIO

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Our enterprise insists all along the standard policy of "product high-quality is base of business survival; client satisfaction could be the staring point and ending of an business; persistent improvement is eternal pursuit of staff" as well as consistent purpose of "reputation first, client first" for Bovine Heparin Preparation, Heparin 5000 Mg, Heparin 5ml, We give priority to quality and customer satisfaction and for this we follow stringent quality control measures. We have in-house testing facilities where our products are tested on every aspect at different processing stages. Owning to latest technologies, we facilitate our customers with customized production facility.
China wholesale Enoxaparin Api - Nadroparin Calcium – CSBIO Detail:

INDICATION:
In surgery, used in moderate or high risk cases of venous thrombosis to prevent venous thromboembolic disease.
Treatment of deep vein thrombosis.
Combined with aspirin for the acute phase of unstable angina and non-Q-wave myocardial infarction.
Prevent the formation of blood clots during cardiopulmonary bypass during hemodialysi
COMPANY ADVANTAGE
1.full product Chains:
We have the full product Chains, which starts from the Porcine mucosa with be processed to Crude heparin, Heparin sodium API that could be depolymerized to the API of Enoxaparin sodium, Dalteaprin sodum and Nadroparin calcium. We could control the product from the starting material and make sure the tracebility which is required by the regulated market. At present, we have our own crude heparin workshop, which could help us to not only control the cost bust also assure the quality of our product.
2.APIs’ Production Lines:
Facilities and Equipment Systems
There are dedicated production workshops respectively for Heparin API, Enoxaparin Sodium API and Dalteparin Sodium&Nadroparin Calcium API. These three workshops are all established and have their respective dedicated production equipments, HVAC system and purify water system, which could avoid the cross contamination.
3.Product qualification
For nadroparin Calcium API : we have Germany and China GMP.
4.Production capacity is enough:Nadroparin Calcium API: 3,000 kg
5.We basically estsabilshed GMP Six-system that can comply with the standard of EU GMP,US FDA CGMP and Chinese GMP which could make sure our product comply with the international quality systems.
6.The company is located in the Zhengding area of China (Hebei) Pilot Free Trade Zone, close to Shijiazhuang Airport and the high-speed railway station, with a good transportation location. On August 26, 2019, the State Council issued the “Overall Plan for China (Hebei) Pilot Free Trade Zone”. The Zhengding area focuses on the development of bio-medicine, international logistics and other industries. We will strive to build the company into a leading enterprise in the domestic heparin industry.
7.Main market:Ukraine, Russia, Indian and so on.
8.Payment: TT in advance
Delivery details: within in 30days after confirmed the order by air
Flow Chart of Nadroparin Calcium
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Nadroparin Calcium (EP)

Tests

Specification

Description

White or almost white powder, hygroscopic.

Solubility

Freely soluble in water.

Identification

13C-NMR-spectrum of substance to be examined should correspond with the reference standard spectrum of Nadroparin calcium.

The ratio of anti-factor Xa activity to anti-factor Ⅱa activity is between 2.5 and 4.0

Average molecular weight should be from 3600 to 5000.

Percentage of factions with molecular weight of less than 2000 should be not more than 15%;

2000-8000: 75-95%;

2000-4000: 35-55%

White crystalline precipitate appears.

Clarity of solution

5% substance solution should stand comparison with the Reference II

Color of solution

5% substance solution should stand comparison with the Reference Y5

pH

From 5.5 to 8.0 (1% solution)

Free sulphates

Not more than 0.5%

N-NO groups

maximum 0.25 ppm

Calcium

From 9.5 to 11.5%

Nitrogen

From 1.5 to 2.5% (calculated on the dried basis)

Sulphate ion to carboxylate ion molecular ratio

Not less than 1.8

Heavy metals

Not more than 30 ppm

Ethanol

Not more than 1.0 per cent m/m

Assay

Anti-factor Xa activity should be from 95 to 130 IU/mg calculated on the dried basis.

Anti-factor Xa activity to anti-factor IIa activity ratio should be from 2.5 to 4.0

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China wholesale Enoxaparin Api - Nadroparin Calcium – CSBIO detail pictures


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All we do is usually connected with our tenet " Customer to start with, Rely on initial, devoting on the food packaging and environmental protection for China wholesale Enoxaparin Api - Nadroparin Calcium – CSBIO , The product will supply to all over the world, such as: Swiss, Angola, Malta, The development of our company not only needs the guarantee of quality, reasonable price and perfect service, but also relies on our customer's trust and support! In the future, we will continue with the most professional and high quality service to provide the most competitive price, Together with our customers and achieve win-win! Welcome to inquiry and consult!
  • The goods are very perfect and the company sales manager is warmful, we will come to this company to purchase next time.
    5 Stars By Sharon from South Africa - 2018.09.08 17:09
    The after-sale warranty service is timely and thoughtful, encounter problems can be resolved very quickly, we feel reliable and secure.
    5 Stars By jari dedenroth from Guatemala - 2018.06.12 16:22
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