01 1Hainan Poly Pharm
02 1TOPHARMAN SHANDONG CO LTD
01 2China
01 2Active
01 2Blank
01 2Blank
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39308
Submission : 2024-01-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38852
Submission : 2023-09-20
Status : Active
Type : II
NDC Package Code : 14335-680
Start Marketing Date : 2023-09-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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.
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