01 1CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN
02 1OLON S.P.A. Rodano IT
03 1R L FINE CHEM PVT. LTD. Gowribidanur IN
04 1VASUDHA PHARMA CHEM LIMITED Hyderabad IN
01 4Nortriptyline hydrochloride
01 3India
02 1Italy
01 4Valid
Certificate Number : CEP 2006-026 - Rev 02
Status : Valid
Issue Date : 2023-10-19
Type : Chemical
Substance Number : 941
Certificate Number : R1-CEP 2013-070 - Rev 02
Status : Valid
Issue Date : 2023-05-31
Type : Chemical
Substance Number : 941
Certificate Number : CEP 2014-032 - Rev 02
Status : Valid
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 941
Certificate Number : R1-CEP 2017-066 - Rev 00
Status : Valid
Issue Date : 2023-07-31
Type : Chemical
Substance Number : 941
A Nortriptyline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nortriptyline, including repackagers and relabelers. The FDA regulates Nortriptyline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nortriptyline 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 Nortriptyline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nortriptyline supplier is an individual or a company that provides Nortriptyline active pharmaceutical ingredient (API) or Nortriptyline finished formulations upon request. The Nortriptyline suppliers may include Nortriptyline API manufacturers, exporters, distributors and traders.
click here to find a list of Nortriptyline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nortriptyline CEP of the European Pharmacopoeia monograph is often referred to as a Nortriptyline Certificate of Suitability (COS). The purpose of a Nortriptyline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nortriptyline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nortriptyline to their clients by showing that a Nortriptyline CEP has been issued for it. The manufacturer submits a Nortriptyline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nortriptyline CEP holder for the record. Additionally, the data presented in the Nortriptyline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nortriptyline DMF.
A Nortriptyline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nortriptyline 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 Nortriptyline suppliers with CEP (COS) on PharmaCompass.
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