01 1Olon S.p.A
02 1Symed Labs
01 2OTILONIUM BROMIDE
01 1India
02 1Italy
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25283
Submission : 2011-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40113
Submission : 2024-06-28
Status : Active
Type : II
A Otilonium Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Otilonium Bromide, including repackagers and relabelers. The FDA regulates Otilonium Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Otilonium 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 Otilonium Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Otilonium Bromide supplier is an individual or a company that provides Otilonium Bromide active pharmaceutical ingredient (API) or Otilonium Bromide finished formulations upon request. The Otilonium Bromide suppliers may include Otilonium Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Otilonium Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Otilonium Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Otilonium Bromide active pharmaceutical ingredient (API) in detail. Different forms of Otilonium Bromide DMFs exist exist since differing nations have different regulations, such as Otilonium Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Otilonium Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Otilonium Bromide USDMF includes data on Otilonium Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Otilonium Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Otilonium Bromide suppliers with USDMF on PharmaCompass.
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