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01 1AMBROXOL HYDROCHLORIDE
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40785
Submission : 2024-11-11
Status : Active
Type : II
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PharmaCompass offers a list of Ambroxol Hydrochloride 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 Ambroxol Hydrochloride manufacturer or Ambroxol Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ambroxol Hydrochloride manufacturer or Ambroxol Hydrochloride supplier.
A Ambril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambril, including repackagers and relabelers. The FDA regulates Ambril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambril 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 Ambril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ambril supplier is an individual or a company that provides Ambril active pharmaceutical ingredient (API) or Ambril finished formulations upon request. The Ambril suppliers may include Ambril API manufacturers, exporters, distributors and traders.
click here to find a list of Ambril suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ambril DMF (Drug Master File) is a document detailing the whole manufacturing process of Ambril active pharmaceutical ingredient (API) in detail. Different forms of Ambril DMFs exist exist since differing nations have different regulations, such as Ambril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ambril DMF submitted to regulatory agencies in the US is known as a USDMF. Ambril USDMF includes data on Ambril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ambril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ambril suppliers with USDMF on PharmaCompass.
