Synbias Pharma: Global Leadership in High-Potency APIs for Oncology and Specialized Therapies
01 1Synbias Pharma AG
02 1Apicore
03 1Biotechnica DWC
04 1ChemPacific Corp
05 2CordenPharma
06 1Pfizer Inc
07 1Viatris
08 1Zhejiang Huida Biotech
01 1Algeria
02 1China
03 2Germany
04 1India
05 1Switzerland
06 3U.S.A
01 2Active
02 1Inactive
03 6Blank
01 9Blank
01 9Blank
01 9Blank
01 9Blank
01 112869-109
02 142533-109
03 7Blank
01 9Blank
Synbias Pharma: Global Leadership in High-Potency APIs for Oncology and Specialized Therapies
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24862
Submission : 2011-07-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18235
Submission : 2005-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2954
Submission : 1977-06-16
Status : Inactive
Type : II
NDC Package Code : 12869-109
Start Marketing Date : 2009-11-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 42533-109
Start Marketing Date : 2009-11-02
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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A Pentostatine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentostatine, including repackagers and relabelers. The FDA regulates Pentostatine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentostatine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Pentostatine supplier is an individual or a company that provides Pentostatine active pharmaceutical ingredient (API) or Pentostatine finished formulations upon request. The Pentostatine suppliers may include Pentostatine API manufacturers, exporters, distributors and traders.
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