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
A Aclidinium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aclidinium Bromide, including repackagers and relabelers. The FDA regulates Aclidinium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aclidinium Bromide 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 Aclidinium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aclidinium Bromide supplier is an individual or a company that provides Aclidinium Bromide active pharmaceutical ingredient (API) or Aclidinium Bromide finished formulations upon request. The Aclidinium Bromide suppliers may include Aclidinium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Aclidinium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aclidinium Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Aclidinium Bromide active pharmaceutical ingredient (API) in detail. Different forms of Aclidinium Bromide DMFs exist exist since differing nations have different regulations, such as Aclidinium Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aclidinium Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Aclidinium Bromide USDMF includes data on Aclidinium Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aclidinium Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aclidinium Bromide suppliers with USDMF on PharmaCompass.
We have 4 companies offering Aclidinium Bromide
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