01 2Boehringer Ingelheim GmbH
02 1C-Squared Pharma
03 1Rolabo Outsourcing
04 1SIGMA TAU
01 2ATROPINE
02 1ATROPINE METHYL NITRATE AS SUPPLIED BY MAC FARALAN SMITH, LIMITED
03 1ATROPINE METHYLNITRATE
04 1ATROPINE USP
01 2Germany
02 1Ireland
03 1Spain
04 1U.S.A
01 1Active
02 4Inactive
01 1Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7334
Submission : 1988-02-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5791
Submission : 1985-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35769
Submission : 2021-05-06
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-23
Pay. Date : 2015-09-22
DMF Number : 29521
Submission : 2015-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5514
Submission : 1983-07-06
Status : Inactive
Type : II
52
PharmaCompass offers a list of Atropine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Atropine manufacturer or Atropine supplier for your needs.
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A DUODOTE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DUODOTE, including repackagers and relabelers. The FDA regulates DUODOTE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DUODOTE 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 DUODOTE supplier is an individual or a company that provides DUODOTE active pharmaceutical ingredient (API) or DUODOTE finished formulations upon request. The DUODOTE suppliers may include DUODOTE API manufacturers, exporters, distributors and traders.
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A DUODOTE DMF (Drug Master File) is a document detailing the whole manufacturing process of DUODOTE active pharmaceutical ingredient (API) in detail. Different forms of DUODOTE DMFs exist exist since differing nations have different regulations, such as DUODOTE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DUODOTE DMF submitted to regulatory agencies in the US is known as a USDMF. DUODOTE USDMF includes data on DUODOTE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DUODOTE USDMF is kept confidential to protect the manufacturer’s intellectual property.
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