GENSENTA ILAC SANAYI AS

GENSENTA ILAC SANAYI AS

CMO & CDMO & FDF MANUFACTURER

About the plant

Gensenta is one of Turkey’s most established pharmaceutical manufacturers, with nearly a century of expertise in sterile production. Since 1923, the company has built a strong legacy of delivering high-quality medicines, combining scientific excellence with a deep-rooted commitment to public health. Today, as a proud member of the Eczac ba Group — one of the most reputable healthcare conglomerates in Turkey — Gensenta continues to expand its global presence with a focus on innovation, reliability, and compliance.

 

At its state-of-the-art facility in Istanbul, Gensenta manufactures a wide range of finished dosage forms including sterile injectables, oral solids, and suspensions. The site operates under the highest international standards and holds key certifications such as FDA approval, EU-GMP, and ISO 14001, 45001, and 50001, ensuring product quality, operational excellence, and environmental responsibility.

 

Gensenta holds a unique position in the Turkish pharmaceutical industry as the first company in the country to export finished drugs to the United States and the first to perform biosimilar fill & finish operations. This pioneering spirit has shaped Gensenta into a trusted Contract Manufacturing Organization (CMO) and strategic partner for companies around the world.

 

With a strong regulatory track record, deep formulation know-how, and a flexible partnership approach, Gensenta offers end-to-end pharmaceutical solutions — from development and scale-up to commercial manufacturing and licensing. We collaborate with pharmaceutical companies of all sizes and geographies, driven by a shared mission: to deliver high-quality, accessible medicines to patients everywhere.

 

At Gensenta, we bring science, experience, and commitment together to help our partners succeed in today’s dynamic global healthcare landscape.

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Compliance

• EMA (EU GMP)
• Health Canada (Canada GMP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• MHRA (UK GMP)
• SFDA (Saudi Food & Drug Authority)
• TITCK (Turkish Health Authorities)

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Activity

• Oral solids / OSD, Injectables, Tablets, Hard capsules, Fill&Finish, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS, SERVICES manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
• Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
• BSL: 1, 2, 3
• Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents
• Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), ANVISA (Brazil), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Extractables & Leachables, Stability tests, Identity, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Particle size (LD), Residual solvents (GC-MS), Elemental impurities / Metals (ICP-MS), Drug Product – Liquid, Drug Product – Solid, API / Excipient – Liquid, API / Excipient – Solid

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