01 1AARTI DRUGS LIMITED Mumbai IN
02 1CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. Shijiazhuang City CN
03 2DR. REDDY'S LABORATORIES LIMITED Hyderabad IN
04 1Farchemia S.r.l. Treviglio IT
05 1KORES (INDIA) LIMITED Navi Mumbai IN
06 2NEULAND LABORATORIES LIMITED Hyderabad IN
07 1ORCHEV PHARMA PRIVATE LIMITED Rajkot IN
08 1SARACA LABORATORIES LIMITED Gaddapotharam Village IN
09 3SMS PHARMACEUTICALS LIMITED Hyderabad IN
10 1SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN
11 1STRIDES SHASUN LIMITED Chennai IN
12 1SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
13 1Union Quimico Farmaceutica, S.A. (Uquifa S.A.) Barcelona ES
14 1Vera Laboratories Ltd Hyderabad IN
15 1Wockhardt Limited Ankleshwar IN
01 9Ranitidine hydrochloride
02 1Ranitidine hydrochloride, (Form II)
03 1Ranitidine hydrochloride, Crystalline powder grade and D.C. grade
04 1Ranitidine hydrochloride, Form - 2
05 2Ranitidine hydrochloride, Form 1
06 1Ranitidine hydrochloride, Form I
07 1Ranitidine hydrochloride, Form II and Form II (DC Grade)
08 1Ranitidine hydrochloride, Form-1
09 1Ranitidine hydrochloride, Form-2
10 1Ranitidine hydrochloride, Form-2, granular
01 1China
02 16India
03 1Italy
04 1Spain
01 5Expired
02 1Suspended by EDQM Failure to CEP procedure
03 3Valid
04 10Withdrawn by Holder
Certificate Number : R1-CEP 2004-057 - Rev 08
Status : Valid
Issue Date : 2022-10-20
Type : Chemical
Substance Number : 946
Certificate Number : CEP 2017-068 - Rev 03
Status : Valid
Issue Date : 2024-03-13
Type : Chemical
Substance Number : 946
Ranitidine Hydrochloride, Form II And Form II (D...
Certificate Number : CEP 2001-228 - Rev 11
Status : Valid
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 946
Certificate Number : R1-CEP 1996-104 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2015-06-08
Type : Chemical
Substance Number : 946
Certificate Number : R1-CEP 1996-102 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2016-06-23
Type : Chemical
Substance Number : 946
Certificate Number : R0-CEP 2000-168 - Rev 01
Status : Expired
Issue Date : 2005-09-27
Type : Chemical
Substance Number : 946
Ranitidine Hydrochloride, Form-1
Certificate Number : R1-CEP 1997-112 - Rev 07
Status : Withdrawn by Holder
Issue Date : 2017-06-02
Type : Chemical
Substance Number : 946
Ranitidine Hydrochloride, Form-2, Granular
Certificate Number : R1-CEP 2003-077 - Rev 05
Status : Withdrawn by Holder
Issue Date : 2017-06-02
Type : Chemical
Substance Number : 946
Ranitidine Hydrochloride, Form-2
Certificate Number : R1-CEP 2002-075 - Rev 05
Status : Withdrawn by Holder
Issue Date : 2016-06-30
Type : Chemical
Substance Number : 946
Ranitidine Hydrochloride, Form 1
Certificate Number : R1-CEP 2000-342 - Rev 05
Status : Withdrawn by Holder
Issue Date : 2016-08-24
Type : Chemical
Substance Number : 946
A Zantac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zantac, including repackagers and relabelers. The FDA regulates Zantac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zantac 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 Zantac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zantac supplier is an individual or a company that provides Zantac active pharmaceutical ingredient (API) or Zantac finished formulations upon request. The Zantac suppliers may include Zantac API manufacturers, exporters, distributors and traders.
click here to find a list of Zantac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zantac CEP of the European Pharmacopoeia monograph is often referred to as a Zantac Certificate of Suitability (COS). The purpose of a Zantac CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zantac EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zantac to their clients by showing that a Zantac CEP has been issued for it. The manufacturer submits a Zantac CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zantac CEP holder for the record. Additionally, the data presented in the Zantac CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zantac DMF.
A Zantac CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zantac 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 Zantac suppliers with CEP (COS) on PharmaCompass.
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