Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Coral Drugs Private Limited
03 1Axplora
04 1Fermion Oy
05 1TAPI Technology & API Services
06 1Amphastar Pharmaceuticals
07 1Astellas Pharma
08 1Cipla
09 2Industriale Chimica
10 1Lusochimica
11 1MSN Laboratories
12 1Sicor Societa Italiana Corticosteroidi Srl
13 1Viatris
14 1Blank
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-10
DMF Number : 16628
Submission : 2003-06-03
Status :
Type : II
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30324
Submission : 2016-06-04
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32936
Submission : 2018-07-27
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-19
Pay. Date : 2019-06-25
DMF Number : 33894
Submission : 2019-07-12
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-12-03
DMF Number : 21357
Submission : 2008-02-22
Status :
Type : II
A Formoterol Fumarate Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Formoterol Fumarate Dihydrate, including repackagers and relabelers. The FDA regulates Formoterol Fumarate Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Formoterol Fumarate Dihydrate supplier is an individual or a company that provides Formoterol Fumarate Dihydrate active pharmaceutical ingredient (API) or Formoterol Fumarate Dihydrate finished formulations upon request. The Formoterol Fumarate Dihydrate suppliers may include Formoterol Fumarate Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Formoterol Fumarate Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Formoterol Fumarate Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Formoterol Fumarate Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Formoterol Fumarate Dihydrate DMFs exist exist since differing nations have different regulations, such as Formoterol Fumarate Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Formoterol Fumarate Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Formoterol Fumarate Dihydrate USDMF includes data on Formoterol Fumarate Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Formoterol Fumarate Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Formoterol Fumarate Dihydrate suppliers with USDMF on PharmaCompass.
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