Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
01 1BAL PHARMA LIMITED Bengaluru IN
02 1AREVIPHARMA GMBH Radebeul DE
03 1FINORTEX, S.L. Sant Llorenç d’Hortons ES
04 1INFAR, S.A. Palafolls ES
05 1MICRO LABS LIMITED Bengaluru IN
06 2RANKE QUIMICA, S.A. Sant Andreu de la Barca ES
07 1VASUDHA PHARMA CHEM LIMITED Hyderabad IN
01 6Ebastine
02 1Ebastine, Micronised
03 1Ebastine, Micronised and non-micronised
01 1Germany
02 3India
03 3Spain
04 1U.S.A
01 8Valid
Certificate Number : CEP 2013-051 - Rev 02
Status : Valid
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 2015
Certificate Number : R1-CEP 2017-287 - Rev 00
Status : Valid
Issue Date : 2023-04-05
Type : Chemical
Substance Number : 2015
Certificate Number : R1-CEP 2015-104 - Rev 01
Status : Valid
Issue Date : 2022-08-22
Type : Chemical
Substance Number : 2015
Certificate Number : CEP 2011-160 - Rev 03
Status : Valid
Issue Date : 2024-10-25
Type : Chemical
Substance Number : 2015
Certificate Number : R0-CEP 2020-139 - Rev 00
Status : Valid
Issue Date : 2021-09-28
Type : Chemical
Substance Number : 2015
Ebastine, Micronised And Non-micronised
Certificate Number : CEP 2017-058 - Rev 01
Status : Valid
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 2015
Certificate Number : R1-CEP 2009-106 - Rev 03
Status : Valid
Issue Date : 2023-07-13
Type : Chemical
Substance Number : 2015
Certificate Number : CEP 2013-243 - Rev 03
Status : Valid
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 2015
A Ebastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ebastine, including repackagers and relabelers. The FDA regulates Ebastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ebastine 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 Ebastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ebastine supplier is an individual or a company that provides Ebastine active pharmaceutical ingredient (API) or Ebastine finished formulations upon request. The Ebastine suppliers may include Ebastine API manufacturers, exporters, distributors and traders.
click here to find a list of Ebastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ebastine CEP of the European Pharmacopoeia monograph is often referred to as a Ebastine Certificate of Suitability (COS). The purpose of a Ebastine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ebastine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ebastine to their clients by showing that a Ebastine CEP has been issued for it. The manufacturer submits a Ebastine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ebastine CEP holder for the record. Additionally, the data presented in the Ebastine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ebastine DMF.
A Ebastine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ebastine 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 Ebastine suppliers with CEP (COS) on PharmaCompass.
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