01 1Alembic Pharmaceuticals Limited
02 2MSN Laboratories
01 1RIOCIGUAT
02 1RIOCIGUAT USP
03 1RIOCIGUAT USP [ROUTE CODE UJ]
01 3India
01 3Active
01 3Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-06-28
DMF Number : 31665
Submission : 2017-06-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-01
Pay. Date : 2017-05-18
DMF Number : 31092
Submission : 2016-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-15
Pay. Date : 2023-08-08
DMF Number : 38372
Submission : 2023-07-01
Status : Active
Type : II
A Riociguat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riociguat, including repackagers and relabelers. The FDA regulates Riociguat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riociguat 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 Riociguat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Riociguat supplier is an individual or a company that provides Riociguat active pharmaceutical ingredient (API) or Riociguat finished formulations upon request. The Riociguat suppliers may include Riociguat API manufacturers, exporters, distributors and traders.
click here to find a list of Riociguat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Riociguat DMF (Drug Master File) is a document detailing the whole manufacturing process of Riociguat active pharmaceutical ingredient (API) in detail. Different forms of Riociguat DMFs exist exist since differing nations have different regulations, such as Riociguat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Riociguat DMF submitted to regulatory agencies in the US is known as a USDMF. Riociguat USDMF includes data on Riociguat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Riociguat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Riociguat suppliers with USDMF on PharmaCompass.
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