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 : 5791
Submission : 1985-03-27
Status : Inactive
Type : II
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 : 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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PharmaCompass also assists you with knowing the Atropine API Price utilized in the formulation of products. Atropine API Price is not always fixed or binding as the Atropine Price is obtained through a variety of data sources. The Atropine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ATNAA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ATNAA, including repackagers and relabelers. The FDA regulates ATNAA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ATNAA 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 ATNAA supplier is an individual or a company that provides ATNAA active pharmaceutical ingredient (API) or ATNAA finished formulations upon request. The ATNAA suppliers may include ATNAA API manufacturers, exporters, distributors and traders.
click here to find a list of ATNAA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ATNAA DMF (Drug Master File) is a document detailing the whole manufacturing process of ATNAA active pharmaceutical ingredient (API) in detail. Different forms of ATNAA DMFs exist exist since differing nations have different regulations, such as ATNAA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ATNAA DMF submitted to regulatory agencies in the US is known as a USDMF. ATNAA USDMF includes data on ATNAA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ATNAA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ATNAA suppliers with USDMF on PharmaCompass.
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