01 1NORDMARK PHARMA GMBH Uetersen DE
02 1SANDOZ GMBH Kundl AT
01 1Pancreas powder, From porcine origin
02 1Pancreas powder, Powder-Granules-Granules F. From Porcine origin
01 2Germany
01 1Valid
02 1Withdrawn by Holder
Pancreas Powder, From Porcine Origin
Certificate Number : CEP 2001-280 - Rev 04
Status : Valid
Issue Date : 2024-11-20
Type : Chemical
Substance Number : 350
Pancreas Powder, Powder-Granules-Granules F. Fro...
Certificate Number : R1-CEP 2001-215 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2010-11-26
Type : Chemical
Substance Number : 350
A Pancrelipase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pancrelipase, including repackagers and relabelers. The FDA regulates Pancrelipase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pancrelipase 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 Pancrelipase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pancrelipase supplier is an individual or a company that provides Pancrelipase active pharmaceutical ingredient (API) or Pancrelipase finished formulations upon request. The Pancrelipase suppliers may include Pancrelipase API manufacturers, exporters, distributors and traders.
click here to find a list of Pancrelipase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pancrelipase CEP of the European Pharmacopoeia monograph is often referred to as a Pancrelipase Certificate of Suitability (COS). The purpose of a Pancrelipase CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pancrelipase EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pancrelipase to their clients by showing that a Pancrelipase CEP has been issued for it. The manufacturer submits a Pancrelipase CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pancrelipase CEP holder for the record. Additionally, the data presented in the Pancrelipase CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pancrelipase DMF.
A Pancrelipase CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pancrelipase 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 Pancrelipase suppliers with CEP (COS) on PharmaCompass.
We have 2 companies offering Pancrelipase
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?