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 : 2023-09-15
Pay. Date : 2023-08-08
DMF Number : 38372
Submission : 2023-07-01
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
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PharmaCompass offers a list of Riociguat 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 Riociguat manufacturer or Riociguat supplier for your needs.
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A Bay 63-2521,Riociguat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bay 63-2521,Riociguat, including repackagers and relabelers. The FDA regulates Bay 63-2521,Riociguat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bay 63-2521,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.
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A Bay 63-2521,Riociguat supplier is an individual or a company that provides Bay 63-2521,Riociguat active pharmaceutical ingredient (API) or Bay 63-2521,Riociguat finished formulations upon request. The Bay 63-2521,Riociguat suppliers may include Bay 63-2521,Riociguat API manufacturers, exporters, distributors and traders.
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A Bay 63-2521,Riociguat DMF (Drug Master File) is a document detailing the whole manufacturing process of Bay 63-2521,Riociguat active pharmaceutical ingredient (API) in detail. Different forms of Bay 63-2521,Riociguat DMFs exist exist since differing nations have different regulations, such as Bay 63-2521,Riociguat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bay 63-2521,Riociguat DMF submitted to regulatory agencies in the US is known as a USDMF. Bay 63-2521,Riociguat USDMF includes data on Bay 63-2521,Riociguat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bay 63-2521,Riociguat USDMF is kept confidential to protect the manufacturer’s intellectual property.
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