01 1Baxter Healthcare Corporation
02 1FandaChem
03 1HAINAN YEW PHARMACEUTICAL CO LTD
04 1Roquette
05 1Shenzhen Haorui
01 3China
02 1France
03 1U.S.A
01 1Active
02 4Blank
01 5Blank
01 5Blank
01 5Blank
01 120240828-211-J-1682
02 4Blank
01 166127-100
02 4Blank
01 5Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14072
Submission : 1999-04-07
Status : Active
Type : II
NDC Package Code : 66127-100
Start Marketing Date : 2006-04-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Rocket Korea Ltd.
Registration Date : 2024-08-28
Registration Number : 20240828-211-J-1682
Manufacturer Name : ROQUETTE FRERES
Manufacturer Address : 1 Rue de la Haute Loge, 62136 LESTREM, France
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PharmaCompass offers a list of Icodextrin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Icodextrin manufacturer or Icodextrin supplier for your needs.
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A Extraneal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Extraneal, including repackagers and relabelers. The FDA regulates Extraneal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Extraneal API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Extraneal supplier is an individual or a company that provides Extraneal active pharmaceutical ingredient (API) or Extraneal finished formulations upon request. The Extraneal suppliers may include Extraneal API manufacturers, exporters, distributors and traders.
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