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Status : Withdrawn by EDQM Failure to CEP pro...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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorobutanol, including repackagers and relabelers. The FDA regulates Chlorobutanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorobutanol 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlorobutanol supplier is an individual or a company that provides Chlorobutanol active pharmaceutical ingredient (API) or Chlorobutanol finished formulations upon request. The Chlorobutanol suppliers may include Chlorobutanol API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorobutanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlorobutanol CEP of the European Pharmacopoeia monograph is often referred to as a Chlorobutanol Certificate of Suitability (COS). The purpose of a Chlorobutanol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chlorobutanol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chlorobutanol to their clients by showing that a Chlorobutanol CEP has been issued for it. The manufacturer submits a Chlorobutanol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chlorobutanol CEP holder for the record. Additionally, the data presented in the Chlorobutanol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chlorobutanol DMF.
A Chlorobutanol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chlorobutanol 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 suppliers with CEP (COS) on PharmaCompass.
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