01 1PCAS Ecully FR
02 1SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan City CN
03 1SYMED LABS LIMITED Hyderabad IN
04 1Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. Hanzhong City CN
05 1TYCHE INDUSTRIES LIMITED Hyderabad IN
01 5Racecadotril
01 2China
02 1France
03 2India
01 5Valid
Certificate Number : R1-CEP 2014-373 - Rev 01
Status : Valid
Issue Date : 2021-08-06
Type : Chemical
Substance Number : 2171
Certificate Number : R1-CEP 2015-239 - Rev 01
Status : Valid
Issue Date : 2023-02-02
Type : Chemical
Substance Number : 2171
Certificate Number : CEP 2016-179 - Rev 01
Status : Valid
Issue Date : 2024-02-20
Type : Chemical
Substance Number : 2171
Certificate Number : R1-CEP 2015-249 - Rev 00
Status : Valid
Issue Date : 2021-07-09
Type : Chemical
Substance Number : 2171
Certificate Number : CEP 2013-223 - Rev 01
Status : Valid
Issue Date : 2024-04-12
Type : Chemical
Substance Number : 2171
A Racecadotril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Racecadotril, including repackagers and relabelers. The FDA regulates Racecadotril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Racecadotril 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 Racecadotril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Racecadotril supplier is an individual or a company that provides Racecadotril active pharmaceutical ingredient (API) or Racecadotril finished formulations upon request. The Racecadotril suppliers may include Racecadotril API manufacturers, exporters, distributors and traders.
click here to find a list of Racecadotril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Racecadotril CEP of the European Pharmacopoeia monograph is often referred to as a Racecadotril Certificate of Suitability (COS). The purpose of a Racecadotril CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Racecadotril EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Racecadotril to their clients by showing that a Racecadotril CEP has been issued for it. The manufacturer submits a Racecadotril CEP (COS) as part of the market authorization procedure, and it takes on the role of a Racecadotril CEP holder for the record. Additionally, the data presented in the Racecadotril CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Racecadotril DMF.
A Racecadotril CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Racecadotril 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 Racecadotril suppliers with CEP (COS) on PharmaCompass.
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