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01 1Alkaloida Chemical Company Zrt
02 1Harman Finochem
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01 1PHENOBARBITAL SODIUM USP
02 1PHENOBARBITAL SODIUM, USP
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01 1Hungary
02 1India
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01 2Active
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01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-31
Pay. Date : 2020-03-06
DMF Number : 34598
Submission : 2020-03-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31499
Submission : 2017-03-16
Status : Active
Type : II
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PharmaCompass offers a list of Phenobarbital Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Phenobarbital Sodium manufacturer or Phenobarbital Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenobarbital Sodium manufacturer or Phenobarbital Sodium supplier.
PharmaCompass also assists you with knowing the Phenobarbital Sodium API Price utilized in the formulation of products. Phenobarbital Sodium API Price is not always fixed or binding as the Phenobarbital Sodium Price is obtained through a variety of data sources. The Phenobarbital Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gardenal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gardenal, including repackagers and relabelers. The FDA regulates Gardenal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gardenal 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 Gardenal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gardenal supplier is an individual or a company that provides Gardenal active pharmaceutical ingredient (API) or Gardenal finished formulations upon request. The Gardenal suppliers may include Gardenal API manufacturers, exporters, distributors and traders.
click here to find a list of Gardenal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gardenal DMF (Drug Master File) is a document detailing the whole manufacturing process of Gardenal active pharmaceutical ingredient (API) in detail. Different forms of Gardenal DMFs exist exist since differing nations have different regulations, such as Gardenal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gardenal DMF submitted to regulatory agencies in the US is known as a USDMF. Gardenal USDMF includes data on Gardenal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gardenal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gardenal suppliers with USDMF on PharmaCompass.
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