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