Certificates of Suitability (CEP/CEPs/COS)

ONY, INC.

  • Product:

    Calf Lung Surfactant Extract

  • Type:

    TSE

  • Substance Number:

    .

  • Substance:

    ONY, INC. Amherst US

  • Status:

    Valid

  • Issue Date:

    2014-05-19

  • Country:

    United States

  • Certificate Number:

    R1-CEP 2008-285 - Rev 00

  • End Date:

OPK Biotech LLC

+1

  • Product:

    Haemoglobin Glutamer 250 (bovine)

  • Type:

    TSE

  • Substance Number:

    .

  • Substance:

    OPK Biotech LLC Cambridge US

  • Status:

    Withdrawn by EDQM Failure to CEP procedure

  • Issue Date:

    2012-12-18

  • Country:

    United States

  • Certificate Number:

    R1-CEP 2002-239 - Rev 01

  • End Date:

    2025-09-29

OPOCRIN SpA Corlo Di Formigine IT

  • Product:

    Heparin calcium, for parenteral preparations

  • Type:

    Chemical and TSE

  • Substance Number:

    332

  • Substance:

    OPOCRIN SpA Corlo Di Formigine IT

  • Status:

    Valid

  • Issue Date:

    2024-07-31

  • Country:

    Italy

  • Certificate Number:

    CEP 2007-211 - Rev 05

  • End Date:

OPOCRIN SpA Formigine IT

  • Product:

    Heparin sodium, For parenteral preparations

  • Type:

    Chemical

  • Substance Number:

    333

  • Substance:

    OPOCRIN SpA Formigine IT

  • Status:

    Valid

  • Issue Date:

    2025-08-07

  • Country:

    Italy

  • Certificate Number:

    CEP 2002-006 - Rev 10

  • End Date:

Opocrin SpA

  • Product:

    Enoxaparin sodium

  • Type:

    Chemical

  • Substance Number:

    1097

  • Substance:

    Opocrin SpA - CORLO PLANT Corlo Di Formigine IT

  • Status:

    Withdrawn by Holder

  • Issue Date:

    2010-08-05

  • Country:

    Italy

  • Certificate Number:

    R1-CEP 2004-014 - Rev 01

  • End Date:

    2012-06-26

Omya SAS

  • Product:

    Calcium carbonate, Sieved grade I (35)

  • Type:

    Chemical

  • Substance Number:

    14

  • Substance:

    OMYA SAS Omey FR

  • Status:

    Valid

  • Issue Date:

    2025-11-21

  • Country:

    France

  • Certificate Number:

    CEP 2001-366 - Rev 05

  • End Date:

Optimus Pharma

+14

  • Product:

    Tioconazole

  • Type:

    Chemical

  • Substance Number:

    2074

  • Substance:

    OPTIMUS DRUGS PRIVATE LIMITED Hyderabad IN

  • Status:

    Valid

  • Issue Date:

    2026-04-13

  • Country:

    India

  • Certificate Number:

    CEP 2020-068 - Rev 03

  • End Date:

OrBion Pharmaceuticals

+1

  • Product:

    Granisetron hydrochloride, Site II

  • Type:

    Chemical

  • Substance Number:

    1695

  • Substance:

    ORBION PHARMACEUTICALS PRIVATE LIMITED Irungattukottai IN

  • Status:

    Valid

  • Issue Date:

    2025-08-27

  • Country:

    India

  • Certificate Number:

    CEP 2020-006 - Rev 02

  • End Date:

Orchev Pharma

+1

  • Product:

    Ranitidine hydrochloride, Crystalline powder grade and D.C. grade

  • Type:

    Chemical

  • Substance Number:

    946

  • Substance:

    ORCHEV PHARMA PRIVATE LIMITED Rajkot IN

  • Status:

    Valid

  • Issue Date:

    2025-06-25

  • Country:

    India

  • Certificate Number:

    CEP 2007-320 - Rev 04

  • End Date:

Orchid Pharma

+4

  • Product:

    Granisetron hydrochloride

  • Type:

    Chemical

  • Substance Number:

    1695

  • Substance:

    ORCHID PHARMA LIMITED Chennai IN

  • Status:

    Withdrawn by Holder

  • Issue Date:

    2016-06-30

  • Country:

    India

  • Certificate Number:

    R1-CEP 2008-087 - Rev 01

  • End Date:

    2022-10-21

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