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List of Certificates of Suitability (CEPs) for Mirtazapine Active Pharmaceutical Ingredient issued by the EDQM and listed on PharmaCompass.com

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Flag Netherlands
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R1-CEP 2010-016 - Rev 03
Valid
Chemical
2022-12-15
2338
Flag India
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2010-293 - Rev 00
Valid
Chemical
2018-04-05
2338
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Digital Content Digital Content
R1-CEP 2008-214 - Rev 03
Valid
Chemical
2023-01-25
2338
Megafine Pharma CB

Supplier's day 2024

Not Confirmed

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Flag India
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R1-CEP 2008-243 - Rev 05
Valid
Chemical
2022-12-19
2338
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URL Supplier Web Content
CEP 2007-062 - Rev 04
Valid
Chemical
2023-12-13
2338
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R1-CEP 2017-010 - Rev 00
Valid
Chemical
2023-03-13
2338
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R0-CEP 2018-225 - Rev 00
Valid
Chemical
2019-02-08
2338
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Flag Israel
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R1-CEP 2008-141 - Rev 03
Valid
Chemical
2021-12-21
2338
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R1-CEP 2009-399 - Rev 04
Valid
Chemical
2022-11-18
2338
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R0-CEP 2019-127 - Rev 01
Valid
Chemical
2022-10-28
2338
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R1-CEP 2008-205 - Rev 05
Valid
Chemical
2022-04-06
2338
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R0-CEP 2020-158 - Rev 01
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Chemical
2023-02-08
2338
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R1-CEP 2009-180 - Rev 02
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Chemical
2019-03-08
2338
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  • TABLET;ORAL - 15MG
  • TABLET;ORAL - 30MG
  • TABLET;ORAL - 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, ORALLY DISINTEGRATING;ORAL - 15MG
  • TABLET, ORALLY DISINTEGRATING;ORAL - 30MG
  • TABLET, ORALLY DISINTEGRATING;ORAL - 45MG

Looking for 61337-67-5 / Mirtazapine API manufacturers, exporters & distributors?

Mirtazapine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Mirtazapine 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 Mirtazapine manufacturer or Mirtazapine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mirtazapine manufacturer or Mirtazapine supplier.

PharmaCompass also assists you with knowing the Mirtazapine API Price utilized in the formulation of products. Mirtazapine API Price is not always fixed or binding as the Mirtazapine Price is obtained through a variety of data sources. The Mirtazapine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Mirtazapine

Synonyms

85650-52-8, Remeron, 61337-67-5, 6-azamianserin, Zispin, Mepirzepine

Cas Number

61337-67-5

Unique Ingredient Identifier (UNII)

A051Q2099Q

About Mirtazapine

A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.

Mirtazapine Manufacturers

A Mirtazapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirtazapine, including repackagers and relabelers. The FDA regulates Mirtazapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirtazapine 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 Mirtazapine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Mirtazapine Suppliers

A Mirtazapine supplier is an individual or a company that provides Mirtazapine active pharmaceutical ingredient (API) or Mirtazapine finished formulations upon request. The Mirtazapine suppliers may include Mirtazapine API manufacturers, exporters, distributors and traders.

click here to find a list of Mirtazapine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Mirtazapine CEP

A Mirtazapine CEP of the European Pharmacopoeia monograph is often referred to as a Mirtazapine Certificate of Suitability (COS). The purpose of a Mirtazapine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mirtazapine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mirtazapine to their clients by showing that a Mirtazapine CEP has been issued for it. The manufacturer submits a Mirtazapine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mirtazapine CEP holder for the record. Additionally, the data presented in the Mirtazapine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mirtazapine DMF.

A Mirtazapine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mirtazapine 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 Mirtazapine suppliers with CEP (COS) on PharmaCompass.

Mirtazapine Manufacturers | Traders | Suppliers

Mirtazapine Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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