01 1Hainan Poly Pharm
02 1TOPHARMAN SHANDONG CO LTD
01 1TECOVIRIMAT
02 1TECOVIRIMAT MONOHYDRATE
01 2China
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38852
Submission : 2023-09-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39308
Submission : 2024-01-04
Status : Active
Type : II
A tecovirimat monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of tecovirimat monohydrate, including repackagers and relabelers. The FDA regulates tecovirimat monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. tecovirimat 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.
A tecovirimat monohydrate supplier is an individual or a company that provides tecovirimat monohydrate active pharmaceutical ingredient (API) or tecovirimat monohydrate finished formulations upon request. The tecovirimat monohydrate suppliers may include tecovirimat monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of tecovirimat monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A tecovirimat monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of tecovirimat monohydrate active pharmaceutical ingredient (API) in detail. Different forms of tecovirimat monohydrate DMFs exist exist since differing nations have different regulations, such as tecovirimat monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A tecovirimat monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. tecovirimat monohydrate USDMF includes data on tecovirimat monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The tecovirimat monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of tecovirimat monohydrate suppliers with USDMF on PharmaCompass.
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