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Relevant Results for

Amiodarone Hydrochloride

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CEP Certificates (EDQM COS List)

ALIVUS LIFE SCIENCES LIMITED Mumbai IN

  • Product:

    Amiodarone hydrochloride

  • Type:

    Chemical

  • Substance Number:

    803

  • Substance:

    ALIVUS LIFE SCIENCES LIMITED Mumbai IN

  • Status:

    Valid

  • Issue Date:

    2025-04-03

  • Country:

    India

  • Certificate Number:

    CEP 2003-216 - Rev 10

  • End Date:

Japan Drug Master Files (JDMF)

Cambrex Profarmaco Milano S. r. l.

  • Product:

    Amiodarone hydrochloride

  • Latest Registration:

    2021-04-08

  • Company:

    Cambrex Profarmaco Milano S. r. l.

  • Initial Registration:

    2006-10-20

  • MF Registration Number:

    218MF10853

  • Registration Category:

    APIs

  • Registered Address:

    Via Curiel 34, 20067 Paulo, Milano, ITALY

KDMF Registration Details

Bansen Co., Ltd.

  • Product:

    Amiodarone hydrochloride

  • Initial Registration:

    2025-06-17

  • Registration Number:

    20250617-210-J-1911

  • MFDS Classification:

    Appendix 1

  • Applicant:

    Bansen Co., Ltd.

  • Last Modified:

  • Country:

    china

  • Status:

    Active

  • Manufacturer:

    Zhejiang Hengkang Pharmaceutical Co., Ltd.

  • Withdrawal Date:

  • Final Annual Reporting Year:

  • Manufacturing Facility:

    No.11 Chengen Road, Pubagang Town, Sanmen, Zhejiang, China

National Drug Code (NDC)

CTX Lifesciences Pvt. Ltd.

  • NDC:

    42419-017

  • Nonproprietary Name:

    Amiodarone Hydrochloride

  • Dosage Form:

    POWDER

  • Product Type:

    BULK INGREDIENT

  • Strength:

    25 kg/25kg

  • Substance:

    AMIODARONE HYDROCHLORIDE

  • Start Marketing Date:

    2013-04-18

  • End Marketing Date:

    0000-00-00

  • DEA Schedule:

  • Certified Through:

    2026-12-31