AMI Lifesciences is Driven by Chemistry. Powered by People.
01 2AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN
02 1ANUH PHARMA LTD. Mumbai IN
03 1Bidachem S.p.A. Fornovo San Giovanni IT
04 1Changzhou Siyao Pharmaceuticals Co., LTD. Changzhou CN
05 1Erregierre S.p.A. San Paolo D'Argon IT
06 1KORES (INDIA) LIMITED Navi Mumbai IN
07 1Kraemer & Martin Pharma Handels GmbH Krefeld DE
08 1OLON S.P.A. Rodano IT
09 1SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN
10 1SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN
11 1Ven PetroChem & Pharma (India) Pvt Ltd Mumbai IN
01 11Ambroxol hydrochloride
02 1Ambroxol hydrochloride, Process II
01 1China
02 1Germany
03 6India
04 3Italy
05 1Blank
01 8Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 3Withdrawn by Holder
AMI Lifesciences is Driven by Chemistry. Powered by People.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Certificate Number : CEP 2014-135 - Rev 03
Status : Valid
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 1489
AMI Lifesciences is Driven by Chemistry. Powered by People.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Ambroxol Hydrochloride, Process II
Certificate Number : R0-CEP 2023-168 - Rev 00
Status : Valid
Issue Date : 2023-08-23
Type : Chemical
Substance Number : 1489
Certificate Number : CEP 2018-033 - Rev 02
Status : Valid
Issue Date : 2024-11-20
Type : Chemical
Substance Number : 1489
Certificate Number : R1-CEP 2002-142 - Rev 03
Status : Valid
Issue Date : 2011-02-10
Type : Chemical
Substance Number : 1489
Certificate Number : R1-CEP 2004-012 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-03-07
Type : Chemical
Substance Number : 1489
Certificate Number : R1-CEP 2002-117 - Rev 02
Status : Valid
Issue Date : 2020-07-10
Type : Chemical
Substance Number : 1489
Certificate Number : R0-CEP 2013-115 - Rev 01
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2016-07-29
Type : Chemical
Substance Number : 1489
Certificate Number : R1-CEP 2004-201 - Rev 05
Status : Valid
Issue Date : 2022-07-20
Type : Chemical
Substance Number : 1489
Certificate Number : R1-CEP 2004-240 - Rev 00
Status : Valid
Issue Date : 2010-11-10
Type : Chemical
Substance Number : 1489
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2023-081 - Rev 00
Status : Valid
Issue Date : 2024-12-02
Type : Chemical
Substance Number : 1489
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Ambroxol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambroxol Hydrochloride, including repackagers and relabelers. The FDA regulates Ambroxol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambroxol Hydrochloride 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 Ambroxol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ambroxol Hydrochloride supplier is an individual or a company that provides Ambroxol Hydrochloride active pharmaceutical ingredient (API) or Ambroxol Hydrochloride finished formulations upon request. The Ambroxol Hydrochloride suppliers may include Ambroxol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ambroxol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ambroxol Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Ambroxol Hydrochloride Certificate of Suitability (COS). The purpose of a Ambroxol Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ambroxol Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ambroxol Hydrochloride to their clients by showing that a Ambroxol Hydrochloride CEP has been issued for it. The manufacturer submits a Ambroxol Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ambroxol Hydrochloride CEP holder for the record. Additionally, the data presented in the Ambroxol Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ambroxol Hydrochloride DMF.
A Ambroxol Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ambroxol Hydrochloride 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 Ambroxol Hydrochloride suppliers with CEP (COS) on PharmaCompass.
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