01 2APEX HEALTHCARE LIMITED
02 1Archimica
03 1Changzhou Sunlight Pharmaceutical Co,Ltd
04 1Chongqing Southwest No.2 Pharma. Factory
05 1Dishman Carbogen Amcis
06 1Jiangsu Jiaerke Pharmaceuticals Group
07 1Jinzhou Jiutai Pharmaceutical
08 1Norbook SRO
09 1Ramdev Chemicals Pvt Ltd
10 1Zhejiang Bamboo Pharmaceuticals
01 4BENZOCAINE
02 1BENZOCAINE (NON-STERILE)
03 4BENZOCAINE USP
04 1BENZOCAINE USP NON STERILE BULK DRUG SUBSTANCE
05 1BENZOCAINE USP-EP
01 5China
02 1Czech Republic
03 4India
04 1Italy
01 4Active
02 7Inactive
01 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36766
Submission : 2022-02-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16638
Submission : 2003-06-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23282
Submission : 2009-11-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32766
Submission : 2018-06-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24523
Submission : 2010-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18105
Submission : 2005-02-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28586
Submission : 2014-06-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11767
Submission : 1995-12-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31899
Submission : 2017-05-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37482
Submission : 2022-09-24
Status : Active
Type : II
A Benzocaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzocaine, including repackagers and relabelers. The FDA regulates Benzocaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzocaine 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 Benzocaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benzocaine supplier is an individual or a company that provides Benzocaine active pharmaceutical ingredient (API) or Benzocaine finished formulations upon request. The Benzocaine suppliers may include Benzocaine API manufacturers, exporters, distributors and traders.
click here to find a list of Benzocaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzocaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzocaine active pharmaceutical ingredient (API) in detail. Different forms of Benzocaine DMFs exist exist since differing nations have different regulations, such as Benzocaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzocaine DMF submitted to regulatory agencies in the US is known as a USDMF. Benzocaine USDMF includes data on Benzocaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzocaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzocaine suppliers with USDMF on PharmaCompass.
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