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 2Cerbios-Pharma SA
07 1Industriale Chimica
08 1Lupin Ltd
01 1TIOTROPIUM BROMIDE MONOHYDRATE
02 3TIOTROPIUM BROMIDE
03 5TIOTROPIUM BROMIDE MONOHYDRATE
04 1TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)
01 1France
02 2Germany
03 2India
04 1Israel
05 1Italy
06 1Spain
07 2Switzerland
01 8Active
02 2Inactive
01 7Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-30
Pay. Date : 2020-01-13
DMF Number : 34410
Submission : 2020-03-17
Status : Active
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 : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-16
Pay. Date : 2013-12-31
DMF Number : 28161
Submission : 2013-12-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-15
Pay. Date : 2013-09-17
DMF Number : 27524
Submission : 2013-10-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18135
Submission : 2005-03-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21939
Submission : 2008-09-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36281
Submission : 2021-10-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-03
Pay. Date : 2015-02-05
DMF Number : 28820
Submission : 2015-01-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-07
Pay. Date : 2023-07-27
DMF Number : 27120
Submission : 2013-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-20
Pay. Date : 2015-11-19
DMF Number : 29726
Submission : 2016-01-20
Status : Active
Type : II
A Tiotropium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tiotropium, including repackagers and relabelers. The FDA regulates Tiotropium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tiotropium 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 Tiotropium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tiotropium supplier is an individual or a company that provides Tiotropium active pharmaceutical ingredient (API) or Tiotropium finished formulations upon request. The Tiotropium suppliers may include Tiotropium API manufacturers, exporters, distributors and traders.
click here to find a list of Tiotropium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tiotropium DMF (Drug Master File) is a document detailing the whole manufacturing process of Tiotropium active pharmaceutical ingredient (API) in detail. Different forms of Tiotropium DMFs exist exist since differing nations have different regulations, such as Tiotropium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tiotropium DMF submitted to regulatory agencies in the US is known as a USDMF. Tiotropium USDMF includes data on Tiotropium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tiotropium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tiotropium suppliers with USDMF on PharmaCompass.
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