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Our Certificates

Quality, Safety & Regulatory Compliance

CARA Yakhteh is committed to the highest standards of quality, safety, and regulatory compliance. Accordingly, the company has adhered to the requirements of Iran’s Food and Drug Administration (IFDA) from the earliest stages of research and development, culminating in the successful completion of preclinical and clinical stages and the subsequent obtaining of IRC (Iranian Registration Certificate).

Official Certificate IFDA Medicine Registration Certificate (Marketing Authorization) - TISAGENLECLEUCEL - CARA Yakhteh
MARKETING AUTHORIZATION

Medicine Registration Certificate

Issuing Authority Food & Drug Administration (IFDA)
Product Name Tisagenlecleucel Injection, Suspension
INN Name TISAGENLECLEUCEL 1 cells INJECTION, SUSPENSION
M.A. / IRC Number 4510396063636322
License Holder CARA Yakhteh Tajhiz Azma Co.
Company National ID 14007103978
Issuance Date December 14, 2025 (1404/09/23)
Validity Period December 14, 2026 (1405/09/23)

Commitment to Quality & Compliance Pillars

Clinical & Preclinical Rigor

Comprehensive preclinical studies and clinical trials conducted in strict adherence to national ethical protocols and international cellular therapy standards.

GMP Cleanroom Operations

State-of-the-art cleanroom manufacturing adhering to Good Manufacturing Practice guidelines with closed-system processing and automated environmental monitoring.

Pharmacovigilance & Safety

Continuous post-market regulatory surveillance and comprehensive patient safety tracking under the oversight of health authorities.

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Official Verification Notice: The validity of this registration certificate is verifiable online via the 2D barcode and official inquiry system of Iran Food and Drug Administration at www.fda.gov.ir.