01 1Bristol Laboratories Ltd
02 1Pfizer Inc
03 1Sandoz B2B
04 1Wyeth Pharmaceuticals Inc
01 3PENICILLIN G BENZATHINE
02 1PENICILLIN G BENZATHINE (STERILE)
01 1Switzerland
02 2U.S.A
03 1United Kingdom
01 1Active
02 3Inactive
01 1Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13655
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13318
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-19
Pay. Date : 2018-03-23
DMF Number : 13294
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13328
Submission : 1998-09-01
Status : Inactive
Type : II
A Penicillin G Benzathine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penicillin G Benzathine, including repackagers and relabelers. The FDA regulates Penicillin G Benzathine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penicillin G Benzathine 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 Penicillin G Benzathine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Penicillin G Benzathine supplier is an individual or a company that provides Penicillin G Benzathine active pharmaceutical ingredient (API) or Penicillin G Benzathine finished formulations upon request. The Penicillin G Benzathine suppliers may include Penicillin G Benzathine API manufacturers, exporters, distributors and traders.
click here to find a list of Penicillin G Benzathine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Penicillin G Benzathine DMF (Drug Master File) is a document detailing the whole manufacturing process of Penicillin G Benzathine active pharmaceutical ingredient (API) in detail. Different forms of Penicillin G Benzathine DMFs exist exist since differing nations have different regulations, such as Penicillin G Benzathine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Penicillin G Benzathine DMF submitted to regulatory agencies in the US is known as a USDMF. Penicillin G Benzathine USDMF includes data on Penicillin G Benzathine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Penicillin G Benzathine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Penicillin G Benzathine suppliers with USDMF on PharmaCompass.
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