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