01 1Chongqing Carelife Pharmaceutical
02 1Hetero Drugs
03 2MSN Laboratories
04 1Zhejiang Huayi Pharmaceutical Co., Ltd.
01 3REGORAFENIB
02 1REGORAFENIB MONOHYDRATE USP
03 1REGORAFENIB [ROUTE CODE "RZ"]
01 2China
02 3India
01 5Active
01 3Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-14
Pay. Date : 2023-05-08
DMF Number : 38197
Submission : 2023-04-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-06
Pay. Date : 2016-05-02
DMF Number : 30490
Submission : 2016-05-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36838
Submission : 2022-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-21
Pay. Date : 2015-11-06
DMF Number : 29870
Submission : 2015-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39898
Submission : 2024-04-27
Status : Active
Type : II
A Regorafenib Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Regorafenib Monohydrate, including repackagers and relabelers. The FDA regulates Regorafenib Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Regorafenib Monohydrate 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 Regorafenib Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Regorafenib Monohydrate supplier is an individual or a company that provides Regorafenib Monohydrate active pharmaceutical ingredient (API) or Regorafenib Monohydrate finished formulations upon request. The Regorafenib Monohydrate suppliers may include Regorafenib Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Regorafenib Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Regorafenib Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Regorafenib Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Regorafenib Monohydrate DMFs exist exist since differing nations have different regulations, such as Regorafenib Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Regorafenib Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Regorafenib Monohydrate USDMF includes data on Regorafenib Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Regorafenib Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Regorafenib Monohydrate suppliers with USDMF on PharmaCompass.
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