01 1Aurisco Pharmaceutical
02 1Pfizer Inc
01 116 BETA METHYL EPOXIDE
02 1BETAMETHYL EPOXIDE
01 1China
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34027
Submission : 2019-12-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11848
Submission : 1996-02-08
Status : Active
Type : II
A Betamethyl Epoxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betamethyl Epoxide, including repackagers and relabelers. The FDA regulates Betamethyl Epoxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betamethyl Epoxide 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 Betamethyl Epoxide supplier is an individual or a company that provides Betamethyl Epoxide active pharmaceutical ingredient (API) or Betamethyl Epoxide finished formulations upon request. The Betamethyl Epoxide suppliers may include Betamethyl Epoxide API manufacturers, exporters, distributors and traders.
click here to find a list of Betamethyl Epoxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betamethyl Epoxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Betamethyl Epoxide active pharmaceutical ingredient (API) in detail. Different forms of Betamethyl Epoxide DMFs exist exist since differing nations have different regulations, such as Betamethyl Epoxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betamethyl Epoxide DMF submitted to regulatory agencies in the US is known as a USDMF. Betamethyl Epoxide USDMF includes data on Betamethyl Epoxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betamethyl Epoxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betamethyl Epoxide suppliers with USDMF on PharmaCompass.
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