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 is your 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
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PharmaCompass offers a list of Formoterol Fumarate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Formoterol Fumarate manufacturer or Formoterol Fumarate supplier for your needs.
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A Dulera manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dulera, including repackagers and relabelers. The FDA regulates Dulera manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dulera API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Dulera supplier is an individual or a company that provides Dulera active pharmaceutical ingredient (API) or Dulera finished formulations upon request. The Dulera suppliers may include Dulera API manufacturers, exporters, distributors and traders.
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A Dulera DMF (Drug Master File) is a document detailing the whole manufacturing process of Dulera active pharmaceutical ingredient (API) in detail. Different forms of Dulera DMFs exist exist since differing nations have different regulations, such as Dulera USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dulera DMF submitted to regulatory agencies in the US is known as a USDMF. Dulera USDMF includes data on Dulera's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dulera USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dulera suppliers with USDMF on PharmaCompass.
We have 13 companies offering Dulera
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