01 1ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN
02 1HEC PHARM CO., LTD. Yidu City CN
03 1Hovione PharmaScience Limited Taipa MO
04 1KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN
05 1Max India Limited Nanjangud IN
06 1SANDOZ INDUSTRIAL PRODUCTS S.A. Les Franqueses Del Vallès ES
07 1ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shangyu CN
08 1ZHEJIANG ZHENYUAN PHARMACEUTICAL CO., LTD. Yuecheng CN
01 7Roxithromycin
02 1Roxithromycin, powder, microfine
01 3China
02 1Germany
03 2India
04 1Portugal
05 1United Kingdom
01 4Valid
02 4Withdrawn by Holder
Certificate Number : CEP 1999-029 - Rev 11
Status : Valid
Issue Date : 2025-02-25
Type : Chemical
Substance Number : 1146
Certificate Number : CEP 2018-207 - Rev 01
Status : Valid
Issue Date : 2025-02-28
Type : Chemical
Substance Number : 1146
Certificate Number : R1-CEP 1999-045 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2008-09-26
Type : Chemical
Substance Number : 1146
Certificate Number : R1-CEP 2001-309 - Rev 03
Status : Valid
Issue Date : 2021-02-17
Type : Chemical
Substance Number : 1146
Certificate Number : R0-CEP 2001-142 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2002-10-03
Type : Chemical
Substance Number : 1146
Roxithromycin, Powder, Microfine
Certificate Number : R1-CEP 2000-094 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2007-05-29
Type : Chemical
Substance Number : 1146
Certificate Number : CEP 2017-064 - Rev 01
Status : Valid
Issue Date : 2024-04-17
Type : Chemical
Substance Number : 1146
Certificate Number : R1-CEP 2003-008 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2009-08-31
Type : Chemical
Substance Number : 1146
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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, 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.
A Heng Te manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heng Te, including repackagers and relabelers. The FDA regulates Heng Te manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heng Te 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 Heng Te supplier is an individual or a company that provides Heng Te active pharmaceutical ingredient (API) or Heng Te finished formulations upon request. The Heng Te suppliers may include Heng Te API manufacturers, exporters, distributors and traders.
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A Heng Te CEP of the European Pharmacopoeia monograph is often referred to as a Heng Te Certificate of Suitability (COS). The purpose of a Heng Te CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Heng Te EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Heng Te to their clients by showing that a Heng Te CEP has been issued for it. The manufacturer submits a Heng Te CEP (COS) as part of the market authorization procedure, and it takes on the role of a Heng Te CEP holder for the record. Additionally, the data presented in the Heng Te CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Heng Te DMF.
A Heng Te CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Heng Te 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 Heng Te suppliers with CEP (COS) on PharmaCompass.
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