Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Vamsi Labs
03 1Seqens
04 1TAPI Technology & API Services
05 2Boehringer Ingelheim GmbH
06 1Breathgreen Pharmaceuticals
07 2Cerbios-Pharma SA
08 1Industriale Chimica
09 1Lupin Ltd
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-30
Pay. Date : 2020-01-13
DMF Number : 34410
Submission : 2020-03-17
Status :
Type : II
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-11
Pay. Date : 2020-11-04
DMF Number : 34808
Submission : 2020-04-15
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-16
Pay. Date : 2013-12-31
DMF Number : 28161
Submission : 2013-12-26
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-15
Pay. Date : 2013-09-17
DMF Number : 27524
Submission : 2013-10-23
Status :
Type : II
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PharmaCompass offers a list of Tiotropium Bromide 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 Tiotropium Bromide manufacturer or Tiotropium Bromide supplier for your needs.
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A Respimat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Respimat, including repackagers and relabelers. The FDA regulates Respimat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Respimat 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 Respimat supplier is an individual or a company that provides Respimat active pharmaceutical ingredient (API) or Respimat finished formulations upon request. The Respimat suppliers may include Respimat API manufacturers, exporters, distributors and traders.
click here to find a list of Respimat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Respimat DMF (Drug Master File) is a document detailing the whole manufacturing process of Respimat active pharmaceutical ingredient (API) in detail. Different forms of Respimat DMFs exist exist since differing nations have different regulations, such as Respimat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Respimat DMF submitted to regulatory agencies in the US is known as a USDMF. Respimat USDMF includes data on Respimat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Respimat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Respimat suppliers with USDMF on PharmaCompass.
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