Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 1MALLADI DRUGS AND PHARMACEUTICALS LIMITED Ranipet IN
02 1AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN
03 1ASAHI KASEI FINECHEM CO., LTD. Osaka JP
04 1CHANGZHOU YINSHENG PHARMACEUTICAL CO., LTD. Changzhou CN
05 1CMIC CMO CO., LTD. Shimada JP
06 1Hunan Dongting Pharmaceutical Co. Ltd Changde CN
07 1KYOWA PHARMA CHEMICAL CO., LTD. Takaoka JP
08 1SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN
01 8Tranexamic acid
01 2China
02 3India
03 3Japan
01 6Valid
02 2Withdrawn by Holder
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Certificate Number : CEP 2022-243 - Rev 00
Status : Valid
Issue Date : 2024-09-13
Type : Chemical
Substance Number : 875
Certificate Number : R0-CEP 2019-250 - Rev 02
Status : Valid
Issue Date : 2022-04-04
Type : Chemical
Substance Number : 875
Certificate Number : R1-CEP 2008-186 - Rev 01
Status : Valid
Issue Date : 2020-05-05
Type : Chemical
Substance Number : 875
Certificate Number : R0-CEP 2009-109 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2011-10-07
Type : Chemical
Substance Number : 875
Certificate Number : R1-CEP 1998-027 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2010-03-04
Type : Chemical
Substance Number : 875
Certificate Number : R1-CEP 2006-142 - Rev 03
Status : Valid
Issue Date : 2023-06-08
Type : Chemical
Substance Number : 875
Certificate Number : R1-CEP 2012-271 - Rev 02
Status : Valid
Issue Date : 2022-09-14
Type : Chemical
Substance Number : 875
Certificate Number : CEP 2018-048 - Rev 02
Status : Valid
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 875
A CAS-1197-18-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-1197-18-8, including repackagers and relabelers. The FDA regulates CAS-1197-18-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-1197-18-8 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 CAS-1197-18-8 supplier is an individual or a company that provides CAS-1197-18-8 active pharmaceutical ingredient (API) or CAS-1197-18-8 finished formulations upon request. The CAS-1197-18-8 suppliers may include CAS-1197-18-8 API manufacturers, exporters, distributors and traders.
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A CAS-1197-18-8 CEP of the European Pharmacopoeia monograph is often referred to as a CAS-1197-18-8 Certificate of Suitability (COS). The purpose of a CAS-1197-18-8 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CAS-1197-18-8 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CAS-1197-18-8 to their clients by showing that a CAS-1197-18-8 CEP has been issued for it. The manufacturer submits a CAS-1197-18-8 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CAS-1197-18-8 CEP holder for the record. Additionally, the data presented in the CAS-1197-18-8 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CAS-1197-18-8 DMF.
A CAS-1197-18-8 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CAS-1197-18-8 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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