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OEM/ODM China Heparin Sodium Side Effects - Nadroparin Calcium – CSBIO

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Our enterprise since its inception, usually regards product top quality as business life, repeatedly enhance manufacturing technology, make improvements to product excellent and continuously strengthen enterprise total high quality administration, in strict accordance with all the national standard ISO 9001:2000 for About Heparin, Dalteparin Fdf, Dalteparin Exporter, We also ensure that your choice is going to be crafted with the highest good quality and dependability. Be sure to feel free of charge to contact us for additional information.
OEM/ODM China Heparin Sodium Side Effects - 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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OEM/ODM China Heparin Sodium Side Effects - Nadroparin Calcium – CSBIO detail pictures


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"Sincerity, Innovation, Rigorousness, and Efficiency" could be the persistent conception of our organization for your long-term to establish alongside one another with shoppers for mutual reciprocity and mutual benefit for OEM/ODM China Heparin Sodium Side Effects - Nadroparin Calcium – CSBIO , The product will supply to all over the world, such as: Madras, Guatemala, Puerto Rico, We insist on the principle of "Credit being primary, Customers being the king and Quality being the best", we are looking forward to the mutual cooperation with all friends at home and abroad and we will create a bright future of business.
  • This manufacturer can keep improving and perfecting products and service, it is in line with the rules of market competition, a competitive company.
    5 Stars By Katherine from Brunei - 2018.06.19 10:42
    The accounts manager made a detailed introduction about the product, so that we have a comprehensive understanding of the product, and ultimately we decided to cooperate.
    5 Stars By Christopher Mabey from California - 2017.06.19 13:51
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