TAPI offers customized CDMO Solutions for API development and manufacturing services.
01 1TAPI Technology & API Services
02 1Archimica
03 2Ash Stevens
04 1Axitec
05 2Bayer AG
06 1Biocare Pharmaceutical
07 1Explora BioLabs
08 1Fred Hutchinson Cancer Center
09 2Hubei Biocause Heilen Pharmaceutical Co., Ltd
10 1Reliable Biopharmaceutical Corporation
11 1Zhejiang Hisun Pharmaceutical
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-12-03
DMF Number : 15742
Submission : 2001-11-12
Status :
Type : II
A Fludarabine Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fludarabine Phosphate, including repackagers and relabelers. The FDA regulates Fludarabine Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fludarabine Phosphate 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 Fludarabine Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fludarabine Phosphate supplier is an individual or a company that provides Fludarabine Phosphate active pharmaceutical ingredient (API) or Fludarabine Phosphate finished formulations upon request. The Fludarabine Phosphate suppliers may include Fludarabine Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Fludarabine Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fludarabine Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fludarabine Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Fludarabine Phosphate DMFs exist exist since differing nations have different regulations, such as Fludarabine Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fludarabine Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Fludarabine Phosphate USDMF includes data on Fludarabine Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fludarabine Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fludarabine Phosphate suppliers with USDMF on PharmaCompass.
We have 11 companies offering Fludarabine Phosphate
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