01 1Alembic Pharmaceuticals Limited
02 1Apicore LLC
03 1Beijing Sjar Technology Development
04 1DEAFARMA
05 1Hetero Drugs
06 1MSN Laboratories
07 1Shandong Haohong Biotechnology Co.,ltd
08 1Sichuan Qingmu Pharmaceutical
09 1Signa S.A. de C.V.
10 1Viatris
01 3China
02 4India
03 1Italy
04 1Mexico
05 1U.S.A
01 3Active
02 7Blank
01 10Blank
01 10Blank
01 1WC-0110n
02 1WC-0349
03 8Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-29
Pay. Date : 2020-11-27
DMF Number : 35413
Submission : 2020-12-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-22
Pay. Date : 2022-06-06
DMF Number : 32340
Submission : 2018-01-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37854
Submission : 2022-12-31
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0124
Start Marketing Date : 2022-12-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110n
Address of the Firm :
NDC Package Code : 42973-242
Start Marketing Date : 2017-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Ponatinib Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ponatinib Hydrochloride, including repackagers and relabelers. The FDA regulates Ponatinib Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ponatinib Hydrochloride 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 Ponatinib Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ponatinib Hydrochloride supplier is an individual or a company that provides Ponatinib Hydrochloride active pharmaceutical ingredient (API) or Ponatinib Hydrochloride finished formulations upon request. The Ponatinib Hydrochloride suppliers may include Ponatinib Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ponatinib Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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