01 1Chemische Fabrik Berg
02 1Cambrex Corporation
03 1Chattem Chemicals, Inc
04 1Mallinckrodt Pharmaceuticals
05 1Pisgah Labs
06 2Sandoz B2B
07 1Siegfried AG
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-06
Pay. Date : 2013-02-20
DMF Number : 4395
Submission : 1981-11-25
Status :
Type : II
84
PharmaCompass offers a list of Butalbital 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 Butalbital manufacturer or Butalbital supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Butalbital manufacturer or Butalbital supplier.
PharmaCompass also assists you with knowing the Butalbital API Price utilized in the formulation of products. Butalbital API Price is not always fixed or binding as the Butalbital Price is obtained through a variety of data sources. The Butalbital Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Butalbital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butalbital, including repackagers and relabelers. The FDA regulates Butalbital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butalbital 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 Butalbital manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butalbital supplier is an individual or a company that provides Butalbital active pharmaceutical ingredient (API) or Butalbital finished formulations upon request. The Butalbital suppliers may include Butalbital API manufacturers, exporters, distributors and traders.
click here to find a list of Butalbital suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Butalbital DMF (Drug Master File) is a document detailing the whole manufacturing process of Butalbital active pharmaceutical ingredient (API) in detail. Different forms of Butalbital DMFs exist exist since differing nations have different regulations, such as Butalbital USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butalbital DMF submitted to regulatory agencies in the US is known as a USDMF. Butalbital USDMF includes data on Butalbital's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butalbital USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butalbital suppliers with USDMF on PharmaCompass.
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