Certificates of Suitability (CEP/CEPs/COS)

SINTENOVO, S.A. DE C.V.

+2

  • Product:

    Esomeprazole sodium

  • Type:

    Chemical

  • Substance Number:

    2923

  • Substance:

    SINTENOVO S.A. DE C.V. Jiutepec MX

  • Status:

    Expired

  • Issue Date:

    2020-12-03

  • Country:

    Mexico

  • Certificate Number:

    R0-CEP 2019-333 - Rev 00

  • End Date:

    2025-12-15

SIONC PHARMACEUTICALS PVT. LTD. Visakhapatnam IN

  • Product:

    Vigabatrin

  • Type:

    Chemical

  • Substance Number:

    2305

  • Substance:

    SIONC PHARMACEUTICALS PVT. LTD. Visakhapatnam IN

  • Status:

    Valid

  • Issue Date:

    2025-07-24

  • Country:

    India

  • Certificate Number:

    CEP 2019-099 - Rev 01

  • End Date:

SMITHKLINE BEECHAM LIMITED Irvine GB

  • Product:

    Potassium clavulanate

  • Type:

    Chemical

  • Substance Number:

    1140

  • Substance:

    SMITHKLINE BEECHAM LIMITED Irvine GB

  • Status:

    Valid

  • Issue Date:

    2024-11-13

  • Country:

    United Kingdom

  • Certificate Number:

    CEP 1999-111 - Rev 04

  • End Date:

Sinbiotik

+2

  • Product:

    Metformin Hydrochloride

  • Type:

    Chemical

  • Substance Number:

    931

  • Substance:

    SINBIOTIK S.A. DE C.V. Tlalnepantla de Baz MX

  • Status:

    Valid

  • Issue Date:

    2024-09-13

  • Country:

    Mexico

  • Certificate Number:

    CEP 2019-060 - Rev 02

  • End Date:

Sinopep Pharmaceutical Inc

+1

  • Product:

    Octreotide

  • Type:

    Chemical

  • Substance Number:

    2414

  • Substance:

    SINOPEP-ALLSINO BIOPHARMACEUTICAL CO., LTD. Lianyungang CN

  • Status:

    Valid

  • Issue Date:

    2025-03-25

  • Country:

    China

  • Certificate Number:

    CEP 2022-302 - Rev 01

  • End Date:

Sintefina Industria E Comercio Ltda

+2

  • Product:

    Bromazepam

  • Type:

    Chemical

  • Substance Number:

    879

  • Substance:

    Sintefina Industria E Comercio Ltda Diadema, Sao Paulo BR

  • Status:

    Withdrawn by EDQM Failure to CEP procedure

  • Issue Date:

    2007-07-03

  • Country:

    Brazil

  • Certificate Number:

    R1-CEP 1998-150 - Rev 02

  • End Date:

    2023-04-11

Sioux Pharm

  • Product:

    Chondroitin sulfate sodium

  • Type:

    TSE

  • Substance Number:

    2064

  • Substance:

    SIOUX PHARM, INC. Sioux Center US

  • Status:

    Valid

  • Issue Date:

    2016-08-31

  • Country:

    United States

  • Certificate Number:

    R1-CEP 2009-218 - Rev 00

  • End Date:

SM BIOMED

+7

  • Product:

    Erythromycin, Process 2

  • Type:

    Chemical

  • Substance Number:

    179

  • Substance:

    SM BIOMED SDN BHD Sungai Petani MY

  • Status:

    Withdrawn by EDQM GMP non-compliance

  • Issue Date:

    2025-03-14

  • Country:

    Malaysia

  • Certificate Number:

    CEP 2020-007 - Rev 01

  • End Date:

    2025-11-14

Smilax Laboratories Limited

+8

  • Product:

    Sildenafil citrate

  • Type:

    Chemical

  • Substance Number:

    2270

  • Substance:

    SMILAX LABORATORIES LIMITED Hyderabad IN

  • Status:

    Valid

  • Issue Date:

    2025-07-30

  • Country:

    India

  • Certificate Number:

    CEP 2024-155 - Rev 00

  • End Date:

Smruthi Organics

+5

  • Product:

    Amlodipine besilate

  • Type:

    Chemical

  • Substance Number:

    1491

  • Substance:

    SMRUTHI ORGANICS LIMITED Solapur IN

  • Status:

    Valid

  • Issue Date:

    2026-06-17

  • Country:

    India

  • Certificate Number:

    CEP 2023-393 - Rev 01

  • End Date:

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