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 5Valid
02 3Withdrawn by Holder
Certificate Number : R1-CEP 1999-029 - Rev 09
Status : Valid
Issue Date : 2018-03-01
Type : Chemical
Substance Number : 1146
Certificate Number : R0-CEP 2018-207 - Rev 00
Status : Valid
Issue Date : 2020-05-29
Type : Chemical
Substance Number : 1146
Certificate Number : R1-CEP 1999-045 - Rev 02
Status : Valid
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Status : Withdrawn by Holder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Status : Withdrawn by Holder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Status : Withdrawn by Holder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
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.
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.
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.
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