Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
01 1Aarti Pharmalabs
02 1Neuland Laboratories
03 1Amphastar Pharmaceuticals
04 1Boehringer Ingelheim GmbH
05 1Cipla
06 1Derivados Quimicos SAU
07 1Lusochimica
08 1Sifavitor srl
01 4IPRATROPIUM BROMIDE
02 1IPRATROPIUM BROMIDE MONOHYDRATE
03 3IPRATROPIUM BROMIDE USP
01 1Germany
02 3India
03 2Italy
04 1Spain
05 1U.S.A
01 6Active
02 2Inactive
01 4Complete
02 4Blank
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21179
Submission : 2007-12-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-15
Pay. Date : 2014-01-03
DMF Number : 15130
Submission : 2000-11-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-16
Pay. Date : 2022-11-04
DMF Number : 31036
Submission : 2017-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14259
Submission : 1999-06-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29843
Submission : 2015-10-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23135
Submission : 2009-09-28
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-05
Pay. Date : 2015-01-27
DMF Number : 8979
Submission : 1991-02-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-17
Pay. Date : 2013-09-12
DMF Number : 8973
Submission : 1991-02-18
Status : Active
Type : II
A Ipratropium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ipratropium Bromide, including repackagers and relabelers. The FDA regulates Ipratropium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ipratropium 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.
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A Ipratropium Bromide supplier is an individual or a company that provides Ipratropium Bromide active pharmaceutical ingredient (API) or Ipratropium Bromide finished formulations upon request. The Ipratropium Bromide suppliers may include Ipratropium Bromide API manufacturers, exporters, distributors and traders.
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A Ipratropium Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Ipratropium Bromide active pharmaceutical ingredient (API) in detail. Different forms of Ipratropium Bromide DMFs exist exist since differing nations have different regulations, such as Ipratropium Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ipratropium Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Ipratropium Bromide USDMF includes data on Ipratropium Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ipratropium Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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