01 1Cadila Pharmaceuticals
02 1Urquima S.A. Grupo Uriach
03 1Vasudha Pharma Chem
01 3RUPATADINE FUMARATE
01 2India
02 1Spain
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26210
Submission : 2012-09-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36047
Submission : 2021-08-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38451
Submission : 2023-05-31
Status : Active
Type : II
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PharmaCompass offers a list of Rupatadine Fumarate 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 Rupatadine Fumarate manufacturer or Rupatadine Fumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rupatadine Fumarate manufacturer or Rupatadine Fumarate supplier.
PharmaCompass also assists you with knowing the Rupatadine Fumarate API Price utilized in the formulation of products. Rupatadine Fumarate API Price is not always fixed or binding as the Rupatadine Fumarate Price is obtained through a variety of data sources. The Rupatadine Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rupatadine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rupatadine, including repackagers and relabelers. The FDA regulates Rupatadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rupatadine 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 Rupatadine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rupatadine supplier is an individual or a company that provides Rupatadine active pharmaceutical ingredient (API) or Rupatadine finished formulations upon request. The Rupatadine suppliers may include Rupatadine API manufacturers, exporters, distributors and traders.
click here to find a list of Rupatadine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rupatadine DMF (Drug Master File) is a document detailing the whole manufacturing process of Rupatadine active pharmaceutical ingredient (API) in detail. Different forms of Rupatadine DMFs exist exist since differing nations have different regulations, such as Rupatadine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rupatadine DMF submitted to regulatory agencies in the US is known as a USDMF. Rupatadine USDMF includes data on Rupatadine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rupatadine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rupatadine suppliers with USDMF on PharmaCompass.
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