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