01 4ACS DOBFAR SPA
02 1Akums Lifesciences
03 1Antibioticos do Brasil Ltda
04 1Asia Pioneer Pharmaceuticals
05 1China Union Chempharma (Suzhou) Co.,Ltd
06 1Eli Lilly
07 1Fresenius Kabi AG
08 1Grand Health Industrial Co Ltd
09 1Hainan Haiyao
10 2Nectar Lifesciences
11 1Orchid Pharma
01 1Brazil
02 3China
03 1Germany
04 4India
05 4Italy
06 2U.S.A
01 2Active
02 4Inactive
03 9Blank
01 1Withdrawn by Holder
02 14Blank
01 1219MF10341
02 14Blank
01 1WC-0131
02 2WC-0145
03 12Blank
01 15Blank
01 110402-021
02 14Blank
01 15Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24679
Submission : 2011-02-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13384
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2004-227 - Rev 03
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 987
Status : Withdrawn by Holder
Registration Number : 219MF10341
Registrant's Address : Rodovia Professor Zeferino Vaz,SP-332 Km 135 Cosmo(\')polis-SP-Brazil ZpC 13151-350
Initial Date of Registration : 2007-11-21
Latest Date of Registration :
NDC Package Code : 10402-021
Start Marketing Date : 2011-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-11-18
Valid Till : 2025-08-06
Written Confirmation Number : WC-0145
Address of the Firm :
Date of Issue : 2022-11-18
Valid Till : 2025-08-06
Written Confirmation Number : WC-0145
Address of the Firm :
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A Keflin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Keflin, including repackagers and relabelers. The FDA regulates Keflin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Keflin 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 Keflin supplier is an individual or a company that provides Keflin active pharmaceutical ingredient (API) or Keflin finished formulations upon request. The Keflin suppliers may include Keflin API manufacturers, exporters, distributors and traders.
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