Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
01 1Transo-Pharm Handels GmbH
02 1Boehringer Ingelheim GmbH
03 1Cambrex Corporation
04 1Viatris
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-16
Pay. Date : 2016-12-28
DMF Number : 30996
Submission : 2016-09-20
Status :
Type : II
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A PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE, including repackagers and relabelers. The FDA regulates PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE supplier is an individual or a company that provides PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE active pharmaceutical ingredient (API) or PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE finished formulations upon request. The PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE suppliers may include PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE API manufacturers, exporters, distributors and traders.
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A PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE DMF (Drug Master File) is a document detailing the whole manufacturing process of PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE active pharmaceutical ingredient (API) in detail. Different forms of PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE DMFs exist exist since differing nations have different regulations, such as PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE DMF submitted to regulatory agencies in the US is known as a USDMF. PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE USDMF includes data on PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 4 companies offering PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
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