Certificates of Suitability (CEP/CEPs/COS)

Industriale Chimica s.r.l.

+30

  • Product:

    Beclometasone dipropionate

  • Type:

    Chemical

  • Substance Number:

    654

  • Substance:

    INDUSTRIALE CHIMICA S.R.L. Saronno IT

  • Status:

    Valid

  • Issue Date:

    2026-04-16

  • Country:

    Italy

  • Certificate Number:

    CEP 2019-108 - Rev 01

  • End Date:

INFAR S.A.

+1

  • Product:

    Ebastine, Micronised and non-micronised

  • Type:

    Chemical

  • Substance Number:

    2015

  • Substance:

    INFAR, S.A. Palafolls ES

  • Status:

    Valid

  • Issue Date:

    2024-06-28

  • Country:

    Spain

  • Certificate Number:

    CEP 2017-058 - Rev 01

  • End Date:

Lukasiewicz Industrial Chemistry Institute

+5

  • Product:

    Tacalcitol, monohydrate

  • Type:

    Chemical

  • Substance Number:

    2272

  • Substance:

    LUKASIEWICZ RESEARCH NETWORK- INDUSTRIAL CHEMISTRY INSTITUTE Warsaw PL

  • Status:

    Valid

  • Issue Date:

    2023-04-27

  • Country:

    Poland

  • Certificate Number:

    R0-CEP 2019-220 - Rev 00

  • End Date:

Aragen Life Sciences

+6

  • Product:

    Lamotrigine

  • Type:

    Chemical

  • Substance Number:

    1756

  • Substance:

    ARAGEN LIFE SCIENCES LIMITED Hyderabad IN

  • Status:

    Valid

  • Issue Date:

    2025-07-24

  • Country:

    India

  • Certificate Number:

    CEP 2010-249 - Rev 07

  • End Date:

Orica

  • Product:

    Acetylsalicylic acid

  • Type:

    Chemical

  • Substance Number:

    309

  • Substance:

    Industria Quimica Andina & Cia. S.A. Bogota D.C CO

  • Status:

    Withdrawn by EDQM Failure to CEP procedure

  • Issue Date:

    2008-12-16

  • Country:

    Colombia

  • Certificate Number:

    R0-CEP 2006-195 - Rev 00

  • End Date:

    2012-04-20

DongWoo Syntech

  • Product:

    Glimepiride

  • Type:

    Chemical

  • Substance Number:

    2223

  • Substance:

    INIST ST CO., LTD. Eumseong-gun KR

  • Status:

    Valid

  • Issue Date:

    2016-02-23

  • Country:

    South Korea

  • Certificate Number:

    R1-CEP 2006-202 - Rev 02

  • End Date:

Inke S.A

+10

  • Product:

    Tiotropium bromide monohydrate, Micronised, non-micronised

  • Type:

    Chemical

  • Substance Number:

    2420

  • Substance:

    INKE, S.A. Castellbisbal ES

  • Status:

    Valid

  • Issue Date:

    2025-10-24

  • Country:

    Spain

  • Certificate Number:

    CEP 2019-337 - Rev 02

  • End Date:

Inner Mongolia Changsheng Pharmaceutical

+6

  • Product:

    Oxytetracycline dihydrate

  • Type:

    Chemical

  • Substance Number:

    199

  • Substance:

    INNER MONGOLIA HUASHU BIOLOGICAL TECHNOLOGY CO.LTD Tongliao City CN

  • Status:

    Valid

  • Issue Date:

    2025-08-13

  • Country:

    China

  • Certificate Number:

    CEP 2018-238 - Rev 01

  • End Date:

Innovare Labs

+8

  • Product:

    Rivaroxaban

  • Type:

    Chemical

  • Substance Number:

    2932

  • Substance:

    INNOVARE LABS PRIVATE LIMITED Visakhapatnam IN

  • Status:

    Valid

  • Issue Date:

    2023-01-17

  • Country:

    India

  • Certificate Number:

    R0-CEP 2021-185 - Rev 00

  • End Date:

Intas Pharmaceuticals

+21

  • Product:

    Capecitabine, Process-III

  • Type:

    Chemical

  • Substance Number:

    2762

  • Substance:

    INTAS PHARMACEUTICALS LIMITED Ahmedabad IN

  • Status:

    Valid

  • Issue Date:

    2026-04-24

  • Country:

    India

  • Certificate Number:

    CEP 2025-176 - Rev 01

  • End Date:

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