Certificates of Suitability (CEP/CEPs/COS)

HIKAL LIMITED Bengaluru IN

  • Product:

    Venlafaxine hydrochloride, Process-C

  • Type:

    Chemical

  • Substance Number:

    2119

  • Substance:

    HIKAL LIMITED Bengaluru IN

  • Status:

    Valid

  • Issue Date:

    2026-03-05

  • Country:

    India

  • Certificate Number:

    CEP 2020-400 - Rev 03

  • End Date:

HIKMA PHARMACEUTICALS LLC Amman JO

  • Product:

    Zoledronic acid monohydrate

  • Type:

    Chemical

  • Substance Number:

    2743

  • Substance:

    HIKMA PHARMACEUTICALS LLC Amman JO

  • Status:

    Valid

  • Issue Date:

    2024-12-13

  • Country:

    Jordan

  • Certificate Number:

    CEP 2023-275 - Rev 00

  • End Date:

Hisun Pharmaceutical Nantong Co., Ltd.

+3

  • Product:

    Praziquantel

  • Type:

    Chemical

  • Substance Number:

    855

  • Substance:

    HISUN PHARMACEUTICAL (NANTONG) CO., LTD. Nantong City CN

  • Status:

    Valid

  • Issue Date:

    2024-09-20

  • Country:

    China

  • Certificate Number:

    CEP 2015-065 - Rev 01

  • End Date:

HUANGSHAN BONSUN PHARMACEUTICALS CO., LTD. Huangshan CN

  • Product:

    Copovidone, K-value: 27.0-33.0

  • Type:

    Chemical

  • Substance Number:

    891

  • Substance:

    HUANGSHAN BONSUN PHARMACEUTICALS CO., LTD. Huangshan CN

  • Status:

    Valid

  • Issue Date:

    2025-10-30

  • Country:

    China

  • Certificate Number:

    CEP 2019-199 - Rev 01

  • End Date:

Hikal

+14

  • Product:

    Dabigatran etexilate mesilate

  • Type:

    Chemical

  • Substance Number:

    3095

  • Substance:

    HIKAL LIMITED Bangalore IN

  • Status:

    Valid

  • Issue Date:

    2025-12-03

  • Country:

    India

  • Certificate Number:

    CEP 2024-363 - Rev 00

  • End Date:

Hikma Pharmaceuticals

  • Product:

    Ondansetron hydrochloride dihydrate

  • Type:

    Chemical

  • Substance Number:

    2016

  • Substance:

    HIKMA PHARMACEUTICALS CO. LTD. Amman JO

  • Status:

    Expired

  • Issue Date:

    2018-08-17

  • Country:

    Jordan

  • Certificate Number:

    R0-CEP 2017-185 - Rev 00

  • End Date:

    2023-08-31

HONOUR LAB LTD

+8

  • Product:

    Dipotassium clorazepate monohydrate

  • Type:

    Chemical

  • Substance Number:

    898

  • Substance:

    HONOUR LAB LIMITED Hyderabad IN

  • Status:

    Valid

  • Issue Date:

    2026-02-02

  • Country:

    India

  • Certificate Number:

    CEP 2024-134 - Rev 00

  • End Date:

Hospira, Inc.

+2

  • Product:

    Oxaliplatin

  • Type:

    Chemical

  • Substance Number:

    2017

  • Substance:

    HOSPIRA BOULDER, INC. Boulder US

  • Status:

    Withdrawn by Holder

  • Issue Date:

    2016-12-20

  • Country:

    United States

  • Certificate Number:

    R1-CEP 2010-259 - Rev 00

  • End Date:

    2019-07-30

Hovione

+15

  • Product:

    Doxycycline hyclate

  • Type:

    Chemical

  • Substance Number:

    272

  • Substance:

    HOVIONE PHARMASCIENCE LIMITED Taipa MO

  • Status:

    Valid

  • Issue Date:

    2026-04-16

  • Country:

  • Certificate Number:

    CEP 1996-066 - Rev 08

  • End Date:

HTL Biotechnology

+3

  • Product:

    Sodium hyaluronate, Alternative process; Intrinsic viscosity : less than 1.8 m3/kg, by fermentation, for parenteral and ophthalmic administration including intra-articular use and intra-ocular use

  • Type:

    Chemical

  • Substance Number:

    1472

  • Substance:

    HTL Javené FR

  • Status:

    Valid

  • Issue Date:

    2024-07-25

  • Country:

    France

  • Certificate Number:

    CEP 2012-335 - Rev 03

  • End Date:

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