01 1CHEMO
02 1Glenmark Life Sciences
03 1Haoyuan Chemexpress Co.Ltd
04 1Johnson & Johnson Innovative Medicine
01 1China
02 1India
03 1Spain
04 1U.S.A
01 1Active
02 1Inactive
03 2Blank
01 4Blank
01 4Blank
01 4Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-28
Pay. Date : 2013-12-05
DMF Number : 27665
Submission : 2014-07-30
Status : Active
Type : II
NDC Package Code : 66039-899
Start Marketing Date : 2013-12-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23787
Submission : 2010-06-24
Status : Inactive
Type : II
A Telaprevir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Telaprevir, including repackagers and relabelers. The FDA regulates Telaprevir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Telaprevir 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 Telaprevir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Telaprevir supplier is an individual or a company that provides Telaprevir active pharmaceutical ingredient (API) or Telaprevir finished formulations upon request. The Telaprevir suppliers may include Telaprevir API manufacturers, exporters, distributors and traders.
click here to find a list of Telaprevir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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