01 1Boehringer Ingelheim GmbH
02 1C-Squared Pharma
03 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
01 3HOMATROPINE HYDROBROMIDE
01 1China
02 1Germany
03 1Ireland
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12067
Submission : 1996-07-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34672
Submission : 2020-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34161
Submission : 2019-09-29
Status : Active
Type : II
A Homatropine Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Homatropine Hydrobromide, including repackagers and relabelers. The FDA regulates Homatropine Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Homatropine Hydrobromide 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 Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Homatropine Hydrobromide supplier is an individual or a company that provides Homatropine Hydrobromide active pharmaceutical ingredient (API) or Homatropine Hydrobromide finished formulations upon request. The Homatropine Hydrobromide suppliers may include Homatropine Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Homatropine Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Homatropine Hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Homatropine Hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of Homatropine Hydrobromide DMFs exist exist since differing nations have different regulations, such as Homatropine Hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Homatropine Hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. Homatropine Hydrobromide USDMF includes data on Homatropine Hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Homatropine Hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Homatropine Hydrobromide suppliers with USDMF on PharmaCompass.
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