ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
01 2ASolution Pharmaceuticals
02 2Fermion Oy
03 2Actavis Inc
04 2Alembic Pharmaceuticals Limited
05 1Assia Chemical Industries Ltd
06 2Cambrex Corporation
07 3F.I.S. Fabbrica Italiana Sintetici
08 3Jinan Jinda Pharmaceutical Chemistry Co Ltd
09 1Lek Pharmaceuticals
10 2Macleods Pharmaceuticals Limited
11 3Maithri Drugs
12 2Mankind Pharma
13 2Omsav Pharma Research
14 1PCA - Prodotti Chimicie Alimentari S.p.A
15 1Roche Diagnostics GmbH
16 1Sandoz B2B
17 4Unimark Remedies Limited
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38079
Submission : 2023-05-10
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-15
Pay. Date : 2019-11-05
DMF Number : 33838
Submission : 2019-10-15
Status :
Type : II
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38080
Submission : 2023-05-10
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-27
Pay. Date : 2019-12-02
DMF Number : 33839
Submission : 2019-11-20
Status :
Type : II
A Nitrofurantoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrofurantoin, including repackagers and relabelers. The FDA regulates Nitrofurantoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrofurantoin 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 Nitrofurantoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitrofurantoin supplier is an individual or a company that provides Nitrofurantoin active pharmaceutical ingredient (API) or Nitrofurantoin finished formulations upon request. The Nitrofurantoin suppliers may include Nitrofurantoin API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrofurantoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitrofurantoin DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitrofurantoin active pharmaceutical ingredient (API) in detail. Different forms of Nitrofurantoin DMFs exist exist since differing nations have different regulations, such as Nitrofurantoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitrofurantoin DMF submitted to regulatory agencies in the US is known as a USDMF. Nitrofurantoin USDMF includes data on Nitrofurantoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitrofurantoin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitrofurantoin suppliers with USDMF on PharmaCompass.
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