01 1FLEMING LABORATORIES LIMITED Nawabpet Village IN
02 1Fleming Laboratories Limited Hyderabad IN
03 2JANSSEN PHARMACEUTICA NV Beerse BE
04 1Janssen Pharmaceutical Ltd County Cork IE
05 1LAKE CHEMICALS PRIVATE LIMITED Shivaji Nagar IN
06 2OLON S.P.A. Rodano IT
07 1TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
08 2VASUDHA PHARMA CHEM LIMITED Hyderabad IN
01 9Loperamide hydrochloride
02 1Loperamide hydrochloride, Process-II
03 1Loperamide oxide monohydrate
01 2Belgium
02 5India
03 1Israel
04 2Italy
05 1U.S.A
01 8Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
Certificate Number : CEP 2016-168 - Rev 03
Status : Valid
Issue Date : 2024-04-19
Type : Chemical
Substance Number : 929
Certificate Number : R2-CEP 1994-020 - Rev 05
Status : Valid
Issue Date : 2019-11-19
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 1996-088 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2001-12-03
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 2004-133 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2012-09-13
Type : Chemical
Substance Number : 1729
Certificate Number : R1-CEP 2009-362 - Rev 02
Status : Valid
Issue Date : 2023-02-14
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 2003-149 - Rev 05
Status : Valid
Issue Date : 2021-06-15
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 2004-132 - Rev 05
Status : Valid
Issue Date : 2020-09-25
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 2008-313 - Rev 03
Status : Valid
Issue Date : 2022-01-04
Type : Chemical
Substance Number : 929
Loperamide Hydrochloride, Process-II
Certificate Number : CEP 2021-341 - Rev 02
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 929
Certificate Number : CEP 2013-333 - Rev 03
Status : Valid
Issue Date : 2024-03-11
Type : Chemical
Substance Number : 929
A Loperamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loperamide, including repackagers and relabelers. The FDA regulates Loperamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loperamide 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 Loperamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loperamide supplier is an individual or a company that provides Loperamide active pharmaceutical ingredient (API) or Loperamide finished formulations upon request. The Loperamide suppliers may include Loperamide API manufacturers, exporters, distributors and traders.
click here to find a list of Loperamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Loperamide CEP of the European Pharmacopoeia monograph is often referred to as a Loperamide Certificate of Suitability (COS). The purpose of a Loperamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Loperamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Loperamide to their clients by showing that a Loperamide CEP has been issued for it. The manufacturer submits a Loperamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Loperamide CEP holder for the record. Additionally, the data presented in the Loperamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Loperamide DMF.
A Loperamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Loperamide 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 Loperamide suppliers with CEP (COS) on PharmaCompass.
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