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