01 1Aarti Drugs
02 1Shasun Chemicals and Drugs Ltd
01 2ROFECOXIB
01 2India
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29858
Submission : 2015-09-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16617
Submission : 2003-05-19
Status : Inactive
Type : II
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PharmaCompass offers a list of Rofecoxib 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 Rofecoxib manufacturer or Rofecoxib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rofecoxib manufacturer or Rofecoxib supplier.
PharmaCompass also assists you with knowing the Rofecoxib API Price utilized in the formulation of products. Rofecoxib API Price is not always fixed or binding as the Rofecoxib Price is obtained through a variety of data sources. The Rofecoxib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rofecoxib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rofecoxib, including repackagers and relabelers. The FDA regulates Rofecoxib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rofecoxib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Rofecoxib supplier is an individual or a company that provides Rofecoxib active pharmaceutical ingredient (API) or Rofecoxib finished formulations upon request. The Rofecoxib suppliers may include Rofecoxib API manufacturers, exporters, distributors and traders.
click here to find a list of Rofecoxib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rofecoxib DMF (Drug Master File) is a document detailing the whole manufacturing process of Rofecoxib active pharmaceutical ingredient (API) in detail. Different forms of Rofecoxib DMFs exist exist since differing nations have different regulations, such as Rofecoxib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rofecoxib DMF submitted to regulatory agencies in the US is known as a USDMF. Rofecoxib USDMF includes data on Rofecoxib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rofecoxib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rofecoxib suppliers with USDMF on PharmaCompass.
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