Aspen API. More than just an API.
01 1Fine Chemicals Corporation (Pty) Ltd. Cape Town ZA
02 1ALKALOIDS PRIVATE LIMITED Secunderabad IN
03 1Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Am Rhein DE
01 3Hyoscine
01 1Germany
02 1India
03 1South Africa
01 2Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 2010-105 - Rev 02
Status : Valid
Issue Date : 2022-03-21
Type : Chemical
Substance Number : 2167
Certificate Number : CEP 2020-045 - Rev 01
Status : Valid
Issue Date : 2023-12-11
Type : Chemical
Substance Number : 2167
Certificate Number : R1-CEP 2006-216 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2014-06-05
Type : Chemical
Substance Number : 2167
A Scopolamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Scopolamine, including repackagers and relabelers. The FDA regulates Scopolamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Scopolamine 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 Scopolamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Scopolamine supplier is an individual or a company that provides Scopolamine active pharmaceutical ingredient (API) or Scopolamine finished formulations upon request. The Scopolamine suppliers may include Scopolamine API manufacturers, exporters, distributors and traders.
click here to find a list of Scopolamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Scopolamine CEP of the European Pharmacopoeia monograph is often referred to as a Scopolamine Certificate of Suitability (COS). The purpose of a Scopolamine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Scopolamine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Scopolamine to their clients by showing that a Scopolamine CEP has been issued for it. The manufacturer submits a Scopolamine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Scopolamine CEP holder for the record. Additionally, the data presented in the Scopolamine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Scopolamine DMF.
A Scopolamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Scopolamine 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 Scopolamine suppliers with CEP (COS) on PharmaCompass.
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