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01 1FERMION OY Espoo FI
02 2CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN
03 1Cambrex Profarmaco Milano S.r.l. Paullo IT
04 1Hexal Syntech GmbH Radebeul DE
05 1LAKE CHEMICALS PRIVATE LIMITED Shivaji Nagar IN
06 1R L FINE CHEM PVT. LTD. Bengaluru IN
07 1TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN
08 1UPJOHN US 2 LLC Morgantown US
01 6Alprazolam
02 1Alprazolam, Milled/micronised
03 1Alprazolam, Non-micronised and micronised
04 1Alprazolam, Process B
01 1Finland
02 1Germany
03 5India
04 2U.S.A
01 8Valid
02 1Withdrawn by Holder
Certificate Number : CEP 2007-365 - Rev 02
Status : Valid
Issue Date : 2025-01-15
Type : Chemical
Substance Number : 1065
Alprazolam, Non-micronised And Micronised
Certificate Number : CEP 2023-265 - Rev 00
Status : Valid
Issue Date : 2024-10-24
Type : Chemical
Substance Number : 1065
Certificate Number : CEP 2014-092 - Rev 01
Status : Valid
Issue Date : 2023-10-19
Type : Chemical
Substance Number : 1065
Certificate Number : CEP 2002-054 - Rev 08
Status : Valid
Issue Date : 2024-11-13
Type : Chemical
Substance Number : 1065
Certificate Number : R0-CEP 1998-111 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2001-12-19
Type : Chemical
Substance Number : 1065
Certificate Number : R1-CEP 2008-229 - Rev 03
Status : Valid
Issue Date : 2023-05-04
Type : Chemical
Substance Number : 1065
Certificate Number : CEP 2007-016 - Rev 02
Status : Valid
Issue Date : 2024-04-25
Type : Chemical
Substance Number : 1065
Certificate Number : CEP 2023-186 - Rev 00
Status : Valid
Issue Date : 2024-10-29
Type : Chemical
Substance Number : 1065
Certificate Number : CEP 2008-060 - Rev 02
Status : Valid
Issue Date : 2024-07-12
Type : Chemical
Substance Number : 1065
A Niravam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niravam, including repackagers and relabelers. The FDA regulates Niravam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niravam 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 Niravam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niravam supplier is an individual or a company that provides Niravam active pharmaceutical ingredient (API) or Niravam finished formulations upon request. The Niravam suppliers may include Niravam API manufacturers, exporters, distributors and traders.
click here to find a list of Niravam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Niravam CEP of the European Pharmacopoeia monograph is often referred to as a Niravam Certificate of Suitability (COS). The purpose of a Niravam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Niravam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Niravam to their clients by showing that a Niravam CEP has been issued for it. The manufacturer submits a Niravam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Niravam CEP holder for the record. Additionally, the data presented in the Niravam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Niravam DMF.
A Niravam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Niravam 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 Niravam suppliers with CEP (COS) on PharmaCompass.
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