Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Bachem AG
03 1USV Private Limited
04 1TAPI Technology & API Services
05 1Alembic Pharmaceuticals Limited
06 1AmbioPharm
07 1Auro Peptides Limited
08 1BCN Peptides
09 1Chengdu Shengnuo Biopharm
10 1Cipla
11 1Fresenius Kabi AB Brunna
12 1Hansoh Pharma
13 1MSN Laboratories
14 1Sun Pharmaceutical Industries Limited
15 1Viatris
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-21
Pay. Date : 2016-09-27
DMF Number : 30526
Submission : 2016-09-27
Status :
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20862
Submission : 2007-09-17
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-08
Pay. Date : 2018-12-03
DMF Number : 33212
Submission : 2018-12-07
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-06
Pay. Date : 2016-04-28
DMF Number : 30476
Submission : 2016-06-09
Status :
Type : II
A Icatibant Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Icatibant Acetate, including repackagers and relabelers. The FDA regulates Icatibant Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Icatibant Acetate 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 Icatibant Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Icatibant Acetate supplier is an individual or a company that provides Icatibant Acetate active pharmaceutical ingredient (API) or Icatibant Acetate finished formulations upon request. The Icatibant Acetate suppliers may include Icatibant Acetate API manufacturers, exporters, distributors and traders.
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A Icatibant Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Icatibant Acetate active pharmaceutical ingredient (API) in detail. Different forms of Icatibant Acetate DMFs exist exist since differing nations have different regulations, such as Icatibant Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Icatibant Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Icatibant Acetate USDMF includes data on Icatibant Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Icatibant Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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