01 1Siegfried AG
01 1CINCHOCAINE BASE AND HCL
01 1Switzerland
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8171
Submission : 1989-08-09
Status : Active
Type : II
A Dibucaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dibucaine Hydrochloride, including repackagers and relabelers. The FDA regulates Dibucaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dibucaine 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 Dibucaine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dibucaine Hydrochloride supplier is an individual or a company that provides Dibucaine Hydrochloride active pharmaceutical ingredient (API) or Dibucaine Hydrochloride finished formulations upon request. The Dibucaine Hydrochloride suppliers may include Dibucaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dibucaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dibucaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dibucaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dibucaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dibucaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dibucaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dibucaine Hydrochloride USDMF includes data on Dibucaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dibucaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dibucaine Hydrochloride suppliers with USDMF on PharmaCompass.
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