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List of Certificates of Suitability (CEPs) for Roxithromycin Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN (1)

02 HEC PHARM CO., LTD. Yidu City CN (1)

03 Hovione PharmaScience Limited Taipa MO (1)

04 KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN (1)

05 Max India Limited Nanjangud IN (1)

06 SANDOZ INDUSTRIAL PRODUCTS S.A. Les Franqueses Del Vallès ES (1)

07 ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shangyu CN (1)

08 ZHEJIANG ZHENYUAN PHARMACEUTICAL CO., LTD. Yuecheng CN (1)

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01 Roxithromycin (7)

02 Roxithromycin, powder, microfine (1)

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01 China (3)

02 Germany (1)

03 India (2)

04 Portugal (1)

05 United Kingdom (1)

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01 Valid (5)

02 Withdrawn by Holder (3)

URL Supplier Web Content
R1-CEP 1999-029 - Rev 09
Valid
Chemical
2018-03-01
1146
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R0-CEP 2018-207 - Rev 00
Valid
Chemical
2020-05-29
1146
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R1-CEP 1999-045 - Rev 02
Valid
Chemical
2008-09-26
1146
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R1-CEP 2001-309 - Rev 03
Valid
Chemical
2021-02-17
1146
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R0-CEP 2001-142 - Rev 00
Withdrawn by Holder
Chemical
2002-10-03
2007-10-03
1146
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R1-CEP 2000-094 - Rev 01
Withdrawn by Holder
Chemical
2007-05-29
2015-11-18
1146
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R0-CEP 2017-064 - Rev 00
Valid
Chemical
2019-03-20
1146
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R1-CEP 2003-008 - Rev 00
Withdrawn by Holder
Chemical
2009-08-31
2019-04-11
1146
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Looking for 80214-83-1 / Roxithromycin API manufacturers, exporters & distributors?

Roxithromycin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Roxithromycin

Synonyms

80214-83-1, Roxithromycine, Roxithromycinum, Roxitromicina, Ru 965, Ru 28965

Cas Number

80214-83-1

Unique Ingredient Identifier (UNII)

21KOF230FA

About Roxithromycin

Semisynthetic derivative of erythromycin. It is concentrated by human phagocytes and is bioactive intracellularly. While the drug is active against a wide spectrum of pathogens, it is particularly effective in the treatment of respiratory and genital tract infections.

Roxithromycin Manufacturers

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

Roxithromycin Suppliers

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

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

Roxithromycin CEP

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

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

Roxithromycin Manufacturers | Traders | Suppliers

Roxithromycin Manufacturers, Traders, Suppliers 1
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We have 8 companies offering Roxithromycin

Get in contact with the supplier of your choice:

  1. Alembic Pharmaceuticals Limited
  2. HEC Pharm
  3. Hovione
  4. Kopran
  5. Max HealthCare LTD
  6. Sandoz B2B
  7. Zhejiang Guobang Pharmaceutical
  8. Zhejiang Zhenyuan Pharmaceutical
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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