Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL
02 1Antibiotice SA Iasi RO
03 1CAPUA BIOSERVICES S.P.A. Capua IT
04 1VUAB PHARMA A.S. Roztoky CZ
01 1Nystatin
02 1Nystatin, Micronised, non-micronised
03 1Nystatin, Non-micronised and micronised
04 1Nystatin, Powder or “micronised” (for extemporaneous oral suspension)
01 1Czech Republic
02 1Italy
03 1Netherlands
04 1Romania
01 3Valid
02 1Withdrawn by Holder
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Nystatin, Powder Or “micronised” (for Extemp...
Certificate Number : CEP 1999-099 - Rev 09
Status : Valid
Issue Date : 2024-03-22
Type : Chemical
Substance Number : 517
Nystatin, Non-micronised And Micronised
Certificate Number : R1-CEP 2003-096 - Rev 04
Status : Valid
Issue Date : 2022-01-28
Type : Chemical
Substance Number : 517
Nystatin, Micronised, Non-micronised
Certificate Number : R0-CEP 2020-247 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2022-10-12
Type : Chemical
Substance Number : 517
Certificate Number : R1-CEP 2003-118 - Rev 07
Status : Valid
Issue Date : 2023-04-11
Type : Chemical
Substance Number : 517
92
PharmaCompass offers a list of Nystatin 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 Nystatin manufacturer or Nystatin supplier for your needs.
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A MYCOLOG-II manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MYCOLOG-II, including repackagers and relabelers. The FDA regulates MYCOLOG-II manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MYCOLOG-II 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 MYCOLOG-II supplier is an individual or a company that provides MYCOLOG-II active pharmaceutical ingredient (API) or MYCOLOG-II finished formulations upon request. The MYCOLOG-II suppliers may include MYCOLOG-II API manufacturers, exporters, distributors and traders.
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A MYCOLOG-II CEP of the European Pharmacopoeia monograph is often referred to as a MYCOLOG-II Certificate of Suitability (COS). The purpose of a MYCOLOG-II CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MYCOLOG-II EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MYCOLOG-II to their clients by showing that a MYCOLOG-II CEP has been issued for it. The manufacturer submits a MYCOLOG-II CEP (COS) as part of the market authorization procedure, and it takes on the role of a MYCOLOG-II CEP holder for the record. Additionally, the data presented in the MYCOLOG-II CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MYCOLOG-II DMF.
A MYCOLOG-II CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MYCOLOG-II CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of MYCOLOG-II suppliers with CEP (COS) on PharmaCompass.
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