Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
01 1OLPHA AS Olaine LV
02 1POLYDRUG LABORATORIES PVT. LTD. Mumbai IN
01 2Chlorobutanol hemihydrate
01 1India
02 1Latvia
01 1Valid
02 1Withdrawn by EDQM Failure to CEP procedure
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Certificate Number : CEP 2013-148 - Rev 01
Status : Valid
Issue Date : 2024-10-28
Type : Chemical
Substance Number : 383
Certificate Number : R0-CEP 2009-112 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2010-06-22
Type : Chemical
Substance Number : 383
A Chlorobutanol Hemihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorobutanol Hemihydrate, including repackagers and relabelers. The FDA regulates Chlorobutanol Hemihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorobutanol Hemihydrate 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 Chlorobutanol Hemihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlorobutanol Hemihydrate supplier is an individual or a company that provides Chlorobutanol Hemihydrate active pharmaceutical ingredient (API) or Chlorobutanol Hemihydrate finished formulations upon request. The Chlorobutanol Hemihydrate suppliers may include Chlorobutanol Hemihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorobutanol Hemihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlorobutanol Hemihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Chlorobutanol Hemihydrate Certificate of Suitability (COS). The purpose of a Chlorobutanol Hemihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chlorobutanol Hemihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chlorobutanol Hemihydrate to their clients by showing that a Chlorobutanol Hemihydrate CEP has been issued for it. The manufacturer submits a Chlorobutanol Hemihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chlorobutanol Hemihydrate CEP holder for the record. Additionally, the data presented in the Chlorobutanol Hemihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chlorobutanol Hemihydrate DMF.
A Chlorobutanol Hemihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chlorobutanol Hemihydrate 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 Chlorobutanol Hemihydrate suppliers with CEP (COS) on PharmaCompass.
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