01 1Erregierre SpA
02 1Kaken Pharmaceuticals
03 1Taro Pharmaceutical Industries
01 2BUTENAFINE HYDROCHLORIDE
02 1BUTENEAFINE HYDROCHLORIDE
01 1Italy
02 1Japan
03 1U.S.A
01 3Active
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18707
Submission : 2005-08-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11296
Submission : 1995-01-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-25
Pay. Date : 2013-01-23
DMF Number : 19551
Submission : 2006-06-27
Status : Active
Type : II
A Butenafine (Hydrochloride) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butenafine (Hydrochloride), including repackagers and relabelers. The FDA regulates Butenafine (Hydrochloride) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butenafine (Hydrochloride) 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 Butenafine (Hydrochloride) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butenafine (Hydrochloride) supplier is an individual or a company that provides Butenafine (Hydrochloride) active pharmaceutical ingredient (API) or Butenafine (Hydrochloride) finished formulations upon request. The Butenafine (Hydrochloride) suppliers may include Butenafine (Hydrochloride) API manufacturers, exporters, distributors and traders.
click here to find a list of Butenafine (Hydrochloride) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Butenafine (Hydrochloride) DMF (Drug Master File) is a document detailing the whole manufacturing process of Butenafine (Hydrochloride) active pharmaceutical ingredient (API) in detail. Different forms of Butenafine (Hydrochloride) DMFs exist exist since differing nations have different regulations, such as Butenafine (Hydrochloride) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butenafine (Hydrochloride) DMF submitted to regulatory agencies in the US is known as a USDMF. Butenafine (Hydrochloride) USDMF includes data on Butenafine (Hydrochloride)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butenafine (Hydrochloride) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butenafine (Hydrochloride) suppliers with USDMF on PharmaCompass.
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