With Fermion, start the journey of your innovative API.
01 2Fermion Oy
02 1Pfanstiehl
03 1CF Pharma
04 1Sichuan Elixir Pharmaceuticals
05 1Alembic Pharmaceuticals Limited
06 1BEDFORD LABS
07 1Benzo Chem Industries Pvt
08 2Fareva
09 1Huzhou Zhanwang Pharmaceutical
10 1LIANYUNGANG GUIKE PHARMACEUTICAL
11 1Mitsubishi Corporation
12 1SEACROSS PHARMACEUTICALS
13 1SIGMA TAU
14 1Zhejiang Hisun Pharmaceutical
15 5Blank
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-08
Pay. Date : 2013-05-23
DMF Number : 4246
Submission : 1981-08-06
Status :
Type : II
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39988
Submission : 2024-06-05
Status :
Type : II
CF Pharma- skilled & highly experienced European API producer based in Hungary.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25957
Submission : 2012-04-10
Status :
Type : II
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 : 39758
Submission : 2024-03-24
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2014-04-17
DMF Number : 23532
Submission : 2010-01-29
Status :
Type : II
A Methotrexate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methotrexate, including repackagers and relabelers. The FDA regulates Methotrexate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methotrexate 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 Methotrexate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methotrexate supplier is an individual or a company that provides Methotrexate active pharmaceutical ingredient (API) or Methotrexate finished formulations upon request. The Methotrexate suppliers may include Methotrexate API manufacturers, exporters, distributors and traders.
click here to find a list of Methotrexate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methotrexate DMF (Drug Master File) is a document detailing the whole manufacturing process of Methotrexate active pharmaceutical ingredient (API) in detail. Different forms of Methotrexate DMFs exist exist since differing nations have different regulations, such as Methotrexate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methotrexate DMF submitted to regulatory agencies in the US is known as a USDMF. Methotrexate USDMF includes data on Methotrexate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methotrexate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methotrexate suppliers with USDMF on PharmaCompass.
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