01 1BBI ENZYMES SA (PTY) LTD Cape Town ZA
02 1BIOINDUSTRIA L.I.M. S.P.A. Novi Ligure IT
03 1Sigma-Aldrich Corporation Saint Louis US
01 1Hyaluronidase
02 1Hyaluronidase, Product codes: 081231, 081236, 081239, 081240, 081242, 081244, 081245, 081246 and 081247
03 1Hyaluronidase, Type VIII, (Product Number H2032)
01 1Italy
02 1South Africa
03 1U.S.A
01 1Expired
02 1Suspended by EDQM GMP non-compliance
03 1Valid
Hyaluronidase, Product Codes: 081231, 081236, 08...
Certificate Number : R1-CEP 2001-085 - Rev 02
Status : Valid
Issue Date : 2010-06-01
Type : TSE
Substance Number : 912
Certificate Number : R1-CEP 2001-068 - Rev 00
Status : Suspended by EDQM GMP non-compliance
Issue Date : 2007-04-04
Type : TSE
Substance Number : 912
Hyaluronidase, Type VIII, (Product Number H2032)
Certificate Number : R0-CEP 2001-364 - Rev 01
Status : Expired
Issue Date : 2005-03-18
Type : TSE
Substance Number : 912
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A HYLENEX RECOMBINANT CEP of the European Pharmacopoeia monograph is often referred to as a HYLENEX RECOMBINANT Certificate of Suitability (COS). The purpose of a HYLENEX RECOMBINANT CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of HYLENEX RECOMBINANT EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of HYLENEX RECOMBINANT to their clients by showing that a HYLENEX RECOMBINANT CEP has been issued for it. The manufacturer submits a HYLENEX RECOMBINANT CEP (COS) as part of the market authorization procedure, and it takes on the role of a HYLENEX RECOMBINANT CEP holder for the record. Additionally, the data presented in the HYLENEX RECOMBINANT CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the HYLENEX RECOMBINANT DMF.
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