01 1AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN
02 2HETERO DRUGS LIMITED Hyderabad IN
01 2Valganciclovir hydrochloride
02 1Valganciclovir hydrochloride, Site-II
01 3India
01 3Valid
Certificate Number : CEP 2023-375 - Rev 00
Status : Valid
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 2930
Valganciclovir Hydrochloride, Site-II
Certificate Number : CEP 2024-111 - Rev 00
Status : Valid
Issue Date : 2024-04-24
Type : Chemical
Substance Number : 2930
Certificate Number : CEP 2022-398 - Rev 00
Status : Valid
Issue Date : 2024-02-14
Type : Chemical
Substance Number : 2930
A Valcyte manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valcyte, including repackagers and relabelers. The FDA regulates Valcyte manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valcyte 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 Valcyte manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valcyte supplier is an individual or a company that provides Valcyte active pharmaceutical ingredient (API) or Valcyte finished formulations upon request. The Valcyte suppliers may include Valcyte API manufacturers, exporters, distributors and traders.
click here to find a list of Valcyte suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valcyte CEP of the European Pharmacopoeia monograph is often referred to as a Valcyte Certificate of Suitability (COS). The purpose of a Valcyte CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Valcyte EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Valcyte to their clients by showing that a Valcyte CEP has been issued for it. The manufacturer submits a Valcyte CEP (COS) as part of the market authorization procedure, and it takes on the role of a Valcyte CEP holder for the record. Additionally, the data presented in the Valcyte CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Valcyte DMF.
A Valcyte CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Valcyte 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 Valcyte suppliers with CEP (COS) on PharmaCompass.
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