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01 1Fermion Oy
02 1Jinan Tantu Chemicals
03 1Sichuan Elixir Pharmaceuticals
04 1TAPI Technology & API Services
05 1Alembic Pharmaceuticals Limited
06 2Guangdong Raffles PharmaTech Co Ltd
07 1Hangzhou Longshine Bio-Tech
08 1MSN Laboratories
09 1Parsian Pharamceutical
10 1Shanghai Hope Chem
11 1Shenzhen Haorui
12 1Shenzhen HwaGen Pharmaceutical
01 8China
02 1Finland
03 2India
04 1Iran
05 1Israel
01 1Active
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01 13Blank
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01 1WC-0349
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Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31080
Submission : 2016-11-10
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 : 54893-0052
Start Marketing Date : 2016-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Dabrafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabrafenib, including repackagers and relabelers. The FDA regulates Dabrafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabrafenib 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 Dabrafenib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dabrafenib supplier is an individual or a company that provides Dabrafenib active pharmaceutical ingredient (API) or Dabrafenib finished formulations upon request. The Dabrafenib suppliers may include Dabrafenib API manufacturers, exporters, distributors and traders.
click here to find a list of Dabrafenib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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