Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1Jiaan Biotech
03 1Nandu Chemicals
04 1Roquette
05 1SMS Pharmaceuticals
01 1France
02 3India
03 1U.S.A
01 2Active
02 3Blank
01 5Blank
01 5Blank
01 5Blank
01 120221207-211-J-1418
02 4Blank
01 150516-004
02 167430-150
03 167835-0035
04 2Blank
01 5Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-14
Pay. Date : 2021-09-09
DMF Number : 9147
Submission : 1991-05-31
Status : Active
Type : II
NDC Package Code : 67430-150
Start Marketing Date : 2017-01-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34499
Submission : 2020-01-15
Status : Active
Type : II
NDC Package Code : 50516-004
Start Marketing Date : 2020-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 67835-0035
Start Marketing Date : 2024-06-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Big Farms Co., Ltd.
Registration Date : 2022-12-07
Registration Number : 20221207-211-J-1418
Manufacturer Name : Nandu Chemical Industries
Manufacturer Address : N-12, Industrial Estate, Hubli-580030, Karnataka, INDIA
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PharmaCompass offers a list of Sodium Gluconate 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 Sodium Gluconate manufacturer or Sodium Gluconate supplier for your needs.
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A Sodium Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Gluconate, including repackagers and relabelers. The FDA regulates Sodium Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Gluconate 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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