01 1DDP SPECIALTY ELECTRONIC MATERIALS US9 LLC Hemlock US
02 1WACKER CHEMIE AG München DE
01 1Simeticone, Q7-2243 LVA
02 1Simeticone, SILFAR S 188
01 1Germany
02 1U.S.A
01 2Valid
Certificate Number : R1-CEP 2009-197 - Rev 03
Status : Valid
Issue Date : 2019-02-07
Type : Chemical
Substance Number : 1470
Certificate Number : R0-CEP 2020-264 - Rev 00
Status : Valid
Issue Date : 2020-10-23
Type : Chemical
Substance Number : 1470
A Simethicone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Simethicone, including repackagers and relabelers. The FDA regulates Simethicone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Simethicone 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 Simethicone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Simethicone supplier is an individual or a company that provides Simethicone active pharmaceutical ingredient (API) or Simethicone finished formulations upon request. The Simethicone suppliers may include Simethicone API manufacturers, exporters, distributors and traders.
click here to find a list of Simethicone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Simethicone CEP of the European Pharmacopoeia monograph is often referred to as a Simethicone Certificate of Suitability (COS). The purpose of a Simethicone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Simethicone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Simethicone to their clients by showing that a Simethicone CEP has been issued for it. The manufacturer submits a Simethicone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Simethicone CEP holder for the record. Additionally, the data presented in the Simethicone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Simethicone DMF.
A Simethicone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Simethicone 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 Simethicone suppliers with CEP (COS) on PharmaCompass.
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