Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Almirall
03 1Hovione
04 1MSN Laboratories
01 1ACLIDINIUM BROMIDE
02 1ACLIDINIUM BROMIDE MICRONIZED
03 1ACLIDINIUM BROMIDE [ROUTE CODE "AU"]
04 1LAS 34273
01 1India
02 1Portugal
03 2Spain
01 3Active
02 1Inactive
01 1Complete
02 3Blank
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-14
Pay. Date : 2023-04-21
DMF Number : 36437
Submission : 2023-03-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16926
Submission : 2003-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34231
Submission : 2019-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28093
Submission : 2014-03-26
Status : Active
Type : II
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PharmaCompass offers a list of Aclidinium 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 Aclidinium Bromide manufacturer or Aclidinium Bromide supplier for your needs.
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A Tudorza Pressair manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tudorza Pressair, including repackagers and relabelers. The FDA regulates Tudorza Pressair manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tudorza Pressair 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 Tudorza Pressair supplier is an individual or a company that provides Tudorza Pressair active pharmaceutical ingredient (API) or Tudorza Pressair finished formulations upon request. The Tudorza Pressair suppliers may include Tudorza Pressair API manufacturers, exporters, distributors and traders.
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A Tudorza Pressair DMF (Drug Master File) is a document detailing the whole manufacturing process of Tudorza Pressair active pharmaceutical ingredient (API) in detail. Different forms of Tudorza Pressair DMFs exist exist since differing nations have different regulations, such as Tudorza Pressair USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tudorza Pressair DMF submitted to regulatory agencies in the US is known as a USDMF. Tudorza Pressair USDMF includes data on Tudorza Pressair's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tudorza Pressair USDMF is kept confidential to protect the manufacturer’s intellectual property.
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