01 1Boehringer Ingelheim GmbH
02 1C-Squared Pharma
03 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
04 1Saurav Chemicals
01 2HOMATROPINE METHYLBROMIDE
02 2HOMATROPINE METHYLBROMIDE USP
01 1China
02 1Germany
03 1India
04 1Ireland
01 3Active
02 1Inactive
01 3Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5441
Submission : 1984-05-24
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-15
Pay. Date : 2017-01-03
DMF Number : 31086
Submission : 2016-12-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-23
Pay. Date : 2015-02-19
DMF Number : 28530
Submission : 2014-07-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-19
Pay. Date : 2014-01-06
DMF Number : 23963
Submission : 2010-07-12
Status : Active
Type : II
A Homatropine Methylbromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Homatropine Methylbromide, including repackagers and relabelers. The FDA regulates Homatropine Methylbromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Homatropine Methylbromide 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 Homatropine Methylbromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Homatropine Methylbromide supplier is an individual or a company that provides Homatropine Methylbromide active pharmaceutical ingredient (API) or Homatropine Methylbromide finished formulations upon request. The Homatropine Methylbromide suppliers may include Homatropine Methylbromide API manufacturers, exporters, distributors and traders.
click here to find a list of Homatropine Methylbromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Homatropine Methylbromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Homatropine Methylbromide active pharmaceutical ingredient (API) in detail. Different forms of Homatropine Methylbromide DMFs exist exist since differing nations have different regulations, such as Homatropine Methylbromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Homatropine Methylbromide DMF submitted to regulatory agencies in the US is known as a USDMF. Homatropine Methylbromide USDMF includes data on Homatropine Methylbromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Homatropine Methylbromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Homatropine Methylbromide suppliers with USDMF on PharmaCompass.
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