01 1Siegfried AG
01 1PROPARACAINE HYDROCHLORIDE
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-29
Pay. Date : 2018-07-23
DMF Number : 2698
Submission : 1976-06-21
Status : Active
Type : II
A Proparacaine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Proparacaine hydrochloride, including repackagers and relabelers. The FDA regulates Proparacaine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Proparacaine 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 Proparacaine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Proparacaine hydrochloride supplier is an individual or a company that provides Proparacaine hydrochloride active pharmaceutical ingredient (API) or Proparacaine hydrochloride finished formulations upon request. The Proparacaine hydrochloride suppliers may include Proparacaine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Proparacaine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Proparacaine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Proparacaine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Proparacaine hydrochloride DMFs exist exist since differing nations have different regulations, such as Proparacaine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Proparacaine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Proparacaine hydrochloride USDMF includes data on Proparacaine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Proparacaine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Proparacaine hydrochloride suppliers with USDMF on PharmaCompass.
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