FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES PARTICLE ENGINEERING in North America

FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES PARTICLE ENGINEERING in North America

Contract manufacturing facility specialized in Oral Solid Dosage (OSD) for clinical and commercial supply, including potent compounds, pilot scale manufacturing and integrated packaging services.

About the plant

This facility is a fully integrated contract manufacturing site specializing in Oral Solid Dosage (OSD) development and production, supporting both clinical and commercial supply. The site offers a wide range of capabilities including blending, granulation (high shear and fluid bed), spray drying, tablet compression, encapsulation, coating, and high-speed inspection.

In addition, the facility provides advanced handling of potent compounds up to OEB3, supported by containment technologies such as isolators and split butterfly valves to ensure operator safety and product integrity.

The site also features a dedicated pilot plant operating at approximately one-tenth of commercial scale, enabling efficient scale-up, process optimization, and seamless technology transfer.

The site includes fully integrated packaging capabilities (bottle and blister), serialization, and automated inspection systems, allowing end-to-end manufacturing and packaging within a single location.

 

With GMP-compliant facilities, on-site analytical laboratories, and a strong track record with global regulatory authorities, the site serves as both a clinical and commercial manufacturing hub, delivering flexible, high-quality solutions to support the full product lifecycle.

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Compliance

• ICH
• EMA (EU GMP)
• FDA (cGMP)
• 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)
• ICHQ3A
• ICHQ3B
• ICHQ3D
• ICHQ1A
• ICHM7

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Activity

• Oral solids / OSD, Tablets, Hard capsules, Granules / Pellets, Powders, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING, Excipients 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)
• Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
• BSL: N/A
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs
• Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), ANVISA (Brazil), MFDS (South Korea), Russian 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, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Milling, OSD (Oral Solid Doses) manufacturing, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Particle size (LD), Residual solvents (GC-MS), Elemental impurities / Metals (ICP-MS), Nitrosamines (HPLC-MS/MS), Drug Product – Solid, API / Excipient – Solid