01 1DMFs Not Supported
02 1Fresenius Kabi AB Brunna
03 1Orchid Pharma
04 1Qilu Antibiotics Pharmaceutical Co., Ltd.
01 2AVIBACTAM SODIUM STERILE
02 1AVIBACTAM SODIUM, STERILE ACTIVE PHARMACEUTICAL INGREDIENT
03 1STERILE AVIBACTAM SODIUM
01 1China
02 1India
03 1Sweden
04 1Blank
01 4Active
01 3Complete
02 1Blank
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36090
Submission : 2021-07-05
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-20
Pay. Date : 2024-02-08
DMF Number : 39510
Submission : 2024-02-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-06
Pay. Date : 2024-02-23
DMF Number : 39355
Submission : 2024-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-25
Pay. Date : 2023-08-22
DMF Number : 38569
Submission : 2023-07-31
Status : Active
Type : II
A Avibactam Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avibactam Sodium, including repackagers and relabelers. The FDA regulates Avibactam Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avibactam Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Avibactam Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Avibactam Sodium supplier is an individual or a company that provides Avibactam Sodium active pharmaceutical ingredient (API) or Avibactam Sodium finished formulations upon request. The Avibactam Sodium suppliers may include Avibactam Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Avibactam Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Avibactam Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Avibactam Sodium active pharmaceutical ingredient (API) in detail. Different forms of Avibactam Sodium DMFs exist exist since differing nations have different regulations, such as Avibactam Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Avibactam Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Avibactam Sodium USDMF includes data on Avibactam Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Avibactam Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Avibactam Sodium suppliers with USDMF on PharmaCompass.
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