01 2Tris Pharma Inc
01 1COD-CPM ER ORAL SUSPENSION
02 1COD-CPM-PSE ER ORAL SUSPENSION
01 2U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29687
Submission : 2015-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27314
Submission : 2013-07-26
Status : Active
Type : II
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A Robitussin AC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Robitussin AC, including repackagers and relabelers. The FDA regulates Robitussin AC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Robitussin AC 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 Robitussin AC manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Robitussin AC supplier is an individual or a company that provides Robitussin AC active pharmaceutical ingredient (API) or Robitussin AC finished formulations upon request. The Robitussin AC suppliers may include Robitussin AC API manufacturers, exporters, distributors and traders.
click here to find a list of Robitussin AC suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Robitussin AC DMF (Drug Master File) is a document detailing the whole manufacturing process of Robitussin AC active pharmaceutical ingredient (API) in detail. Different forms of Robitussin AC DMFs exist exist since differing nations have different regulations, such as Robitussin AC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Robitussin AC DMF submitted to regulatory agencies in the US is known as a USDMF. Robitussin AC USDMF includes data on Robitussin AC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Robitussin AC USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Robitussin AC suppliers with USDMF on PharmaCompass.
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