01 1Chattem Chemicals, Inc
02 1Lonza Group
01 1HYDROXYAMPHETAMINE HYDROBROMIDE
02 1HYDROXYAMPHETAMINE HYDROBROMIDE USP
01 1Switzerland
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10334
Submission : 1993-07-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4402
Submission : 1981-12-23
Status : Inactive
Type : II
A P-Hydroxyamphetamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of P-Hydroxyamphetamine, including repackagers and relabelers. The FDA regulates P-Hydroxyamphetamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. P-Hydroxyamphetamine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A P-Hydroxyamphetamine supplier is an individual or a company that provides P-Hydroxyamphetamine active pharmaceutical ingredient (API) or P-Hydroxyamphetamine finished formulations upon request. The P-Hydroxyamphetamine suppliers may include P-Hydroxyamphetamine API manufacturers, exporters, distributors and traders.
click here to find a list of P-Hydroxyamphetamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A P-Hydroxyamphetamine DMF (Drug Master File) is a document detailing the whole manufacturing process of P-Hydroxyamphetamine active pharmaceutical ingredient (API) in detail. Different forms of P-Hydroxyamphetamine DMFs exist exist since differing nations have different regulations, such as P-Hydroxyamphetamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A P-Hydroxyamphetamine DMF submitted to regulatory agencies in the US is known as a USDMF. P-Hydroxyamphetamine USDMF includes data on P-Hydroxyamphetamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The P-Hydroxyamphetamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of P-Hydroxyamphetamine suppliers with USDMF on PharmaCompass.
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