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
A Rinialer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rinialer, including repackagers and relabelers. The FDA regulates Rinialer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rinialer 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 Rinialer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rinialer supplier is an individual or a company that provides Rinialer active pharmaceutical ingredient (API) or Rinialer finished formulations upon request. The Rinialer suppliers may include Rinialer API manufacturers, exporters, distributors and traders.
click here to find a list of Rinialer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rinialer DMF (Drug Master File) is a document detailing the whole manufacturing process of Rinialer active pharmaceutical ingredient (API) in detail. Different forms of Rinialer DMFs exist exist since differing nations have different regulations, such as Rinialer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rinialer DMF submitted to regulatory agencies in the US is known as a USDMF. Rinialer USDMF includes data on Rinialer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rinialer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rinialer suppliers with USDMF on PharmaCompass.
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