01 1ALLEGRANZI MIKRONEVE S.A.S. DI ALLEGRANZI S.R.L. Cordignano IT
02 1IMERYS CARBONATES AUSTRIA GMBH Ebensee AT
03 1IMERYS CARBONATES USA INC. Roswell US
04 1J.M. HUBER MICROPOWDERS, INC. Atlanta US
05 2MINERARIA SACILESE S.P.A. Sacile IT
06 1OMYA SAS Omey FR
07 1SCORA Caffiers FR
08 2SUDEEP PHARMA LIMITED Vadodara IN
09 1Shanghai NuoCheng Pharmaceutical Co., Ltd. Shanghai CN
10 1Società Generale per l'Industria della Magnesia S.p.A. Angera (Va) IT
11 1Specialty Minerals Lifford Birmingham GB
01 9Calcium carbonate
02 1Calcium carbonate, Granular
03 1Calcium carbonate, Micronised 18
04 1Calcium carbonate, Micronised 30
05 1Calcium carbonate, Sieved grade I (35)
01 1China
02 4France
03 2India
04 3Italy
05 2U.S.A
06 1Blank
01 13Valid
Certificate Number : R1-CEP 1996-025 - Rev 02
Status : Valid
Issue Date : 2006-06-23
Type : Chemical
Substance Number : 14
Certificate Number : CEP 2018-214 - Rev 01
Status : Valid
Issue Date : 2024-08-16
Type : Chemical
Substance Number : 14
Certificate Number : R1-CEP 2004-091 - Rev 02
Status : Valid
Issue Date : 2021-09-16
Type : Chemical
Substance Number : 14
Calcium Carbonate, Micronised 30
Certificate Number : CEP 2016-258 - Rev 01
Status : Valid
Issue Date : 2024-10-04
Type : Chemical
Substance Number : 14
Calcium Carbonate, Micronised 18
Certificate Number : CEP 2024-306 - Rev 00
Status : Valid
Issue Date : 2024-12-02
Type : Chemical
Substance Number : 14
Calcium Carbonate, Sieved Grade I (35)
Certificate Number : CEP 2001-366 - Rev 05
Status : Valid
Issue Date : 2025-11-21
Type : Chemical
Substance Number : 14
Certificate Number : CEP 1997-065 - Rev 05
Status : Valid
Issue Date : 2025-06-13
Type : Chemical
Substance Number : 14
Certificate Number : R1-CEP 2007-132 - Rev 01
Status : Valid
Issue Date : 2022-02-10
Type : Chemical
Substance Number : 14
Certificate Number : CEP 2013-299 - Rev 03
Status : Valid
Issue Date : 2025-03-11
Type : Chemical
Substance Number : 14
Certificate Number : CEP 2020-379 - Rev 02
Status : Valid
Issue Date : 2025-03-11
Type : Chemical
Substance Number : 14
46
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A Atomit manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atomit, including repackagers and relabelers. The FDA regulates Atomit manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atomit API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Atomit supplier is an individual or a company that provides Atomit active pharmaceutical ingredient (API) or Atomit finished formulations upon request. The Atomit suppliers may include Atomit API manufacturers, exporters, distributors and traders.
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A Atomit CEP of the European Pharmacopoeia monograph is often referred to as a Atomit Certificate of Suitability (COS). The purpose of a Atomit CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atomit EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atomit to their clients by showing that a Atomit CEP has been issued for it. The manufacturer submits a Atomit CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atomit CEP holder for the record. Additionally, the data presented in the Atomit CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atomit DMF.
A Atomit CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atomit CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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