Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1Antibiotice SA
03 4Bristol Myers Squibb
04 1Olon S.p.A
05 1Pfizer Inc
06 1VUAB Pharma
07 1Blank
01 1MYCOSTATIN (NYSTATIN)
02 1MYCOSTATIN -20 IN PIGS (VET)
03 6NYSTATIN
04 1NYSTATIN BULK POWDER
05 1NYSTATIN USP
01 1Czech Republic
02 1Italy
03 1Netherlands
04 1Romania
05 5U.S.A
06 1Blank
01 4Active
02 6Inactive
01 4Complete
02 6Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-07
Pay. Date : 2013-07-29
DMF Number : 13523
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-21
DMF Number : 14813
Submission : 2000-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13298
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1740
Submission : 1971-06-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 708
Submission : 1963-04-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13441
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-28
Pay. Date : 2020-11-05
DMF Number : 35225
Submission : 2020-11-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15028
Submission : 2000-09-13
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-16
Pay. Date : 2014-01-09
DMF Number : 14056
Submission : 1999-04-05
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12557
Submission : 1997-06-19
Status : Inactive
Type : II
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A Nystatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nystatin, including repackagers and relabelers. The FDA regulates Nystatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nystatin 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 Nystatin supplier is an individual or a company that provides Nystatin active pharmaceutical ingredient (API) or Nystatin finished formulations upon request. The Nystatin suppliers may include Nystatin API manufacturers, exporters, distributors and traders.
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A Nystatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Nystatin active pharmaceutical ingredient (API) in detail. Different forms of Nystatin DMFs exist exist since differing nations have different regulations, such as Nystatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nystatin DMF submitted to regulatory agencies in the US is known as a USDMF. Nystatin USDMF includes data on Nystatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nystatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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