Athena Athena

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List of Certificates of Suitability (CEPs) for AM 7 Active Pharmaceutical Ingredient issued by the EDQM and listed on PharmaCompass.com

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R1-CEP 2007-226 - Rev 03
Valid
Chemical
2019-04-24
260
Centrient Pharmaceuticals

2024 ACI Convention

Not Confirmed

envelop Contact Supplier
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R1-CEP 2001-367 - Rev 05
Valid
Chemical
2019-03-21
260
Centrient Pharmaceuticals

2024 Spring Meeting

Not Confirmed

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R1-CEP 2001-123 - Rev 03
Withdrawn by Holder
Chemical
2015-02-16
2022-03-14
260
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CEP 2017-037 - Rev 02
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Chemical
2023-11-28
260
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CEP 2007-147 - Rev 05
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Chemical
2023-11-30
260
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R1-CEP 2012-245 - Rev 00
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Chemical
2018-01-26
2019-09-16
260
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R1-CEP 2004-147 - Rev 00
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2013-04-22
2019-09-16
260
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R1-CEP 2015-064 - Rev 00
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2021-03-03
260
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R1-CEP 2000-010 - Rev 04
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2018-06-04
260
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R1-CEP 2007-315 - Rev 02
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2020-01-31
260
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R1-CEP 2016-310 - Rev 00
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2022-03-08
260
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R0-CEP 1997-129 - Rev 00
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2005-01-24
2011-03-11
260
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CEP 2017-009 - Rev 01
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2023-09-05
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CEP 2014-220 - Rev 02
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2023-09-05
260
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R1-CEP 2009-329 - Rev 00
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2015-03-17
2019-05-28
260
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R1-CEP 2004-074 - Rev 00
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2013-04-30
2019-05-28
260
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R1-CEP 1996-060 - Rev 03
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2010-12-20
2021-04-08
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R1-CEP 2004-266 - Rev 01
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2012-11-16
2015-07-29
260
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NA Not Available For Sales
R0-CEP 2018-178 - Rev 01
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2020-08-19
260
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R2-CEP 1995-030 - Rev 02
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2014-06-02
2023-09-11
260
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R2-CEP 1995-034 - Rev 06
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2015-11-12
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R0-CEP 2007-018 - Rev 02
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2014-09-08
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CEP 2023-277 - Rev 00
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2023-09-18
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CEP 2021-461 - Rev 01
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CEP 2019-244 - Rev 02
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R1-CEP 1997-028 - Rev 04
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R1-CEP 2004-146 - Rev 02
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2022-03-07
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R1-CEP 2012-078 - Rev 02
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2022-04-13
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DSM Anti-Infectives B.V. Delft NL

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R2-CEP 1994-013 - Rev 03
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2009-07-03
2018-01-10
260
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DSM Anti-Infectives India LIMITED T...

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R1-CEP 2001-351 - Rev 01
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2008-01-23
2011-05-23
260
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DSM Anti-Infectives B.V. Delft NL

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R2-CEP 1995-014 - Rev 01
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2006-02-21
2011-05-23
260
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R1-CEP 2007-191 - Rev 03
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2019-02-06
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R1-CEP 2006-039 - Rev 02
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2020-10-16
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  • TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
  • FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
  • TABLET;ORAL - 875MG;EQ 125MG BASE
  • FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
  • FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
  • TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
  • CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - 775MG
  • CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 61336-70-7 / Amoxicillin Trihydrate API manufacturers, exporters & distributors?

Amoxicillin Trihydrate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Amoxicillin Trihydrate

Synonyms

61336-70-7, Larotid, Polymox, Trimox, Utimox, Wymox

Cas Number

61336-70-7

Unique Ingredient Identifier (UNII)

804826J2HU

About Amoxicillin Trihydrate

A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.

AM 7 Manufacturers

A AM 7 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AM 7, including repackagers and relabelers. The FDA regulates AM 7 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AM 7 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 AM 7 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

AM 7 Suppliers

A AM 7 supplier is an individual or a company that provides AM 7 active pharmaceutical ingredient (API) or AM 7 finished formulations upon request. The AM 7 suppliers may include AM 7 API manufacturers, exporters, distributors and traders.

click here to find a list of AM 7 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

AM 7 CEP

A AM 7 CEP of the European Pharmacopoeia monograph is often referred to as a AM 7 Certificate of Suitability (COS). The purpose of a AM 7 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AM 7 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AM 7 to their clients by showing that a AM 7 CEP has been issued for it. The manufacturer submits a AM 7 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AM 7 CEP holder for the record. Additionally, the data presented in the AM 7 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AM 7 DMF.

A AM 7 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AM 7 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 AM 7 suppliers with CEP (COS) on PharmaCompass.

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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