FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES PARTICLE ENGINEERING in North America
Commercial-scale oral solid dosage (OSD) manufacturing facility with strong expertise in controlled substances (DEA II V), offering end-to-end production, packaging, and analytical support for global...
About the plant
The facility is a large-scale, multi-product oral solid dosage (OSD) manufacturing site located in USA. The site operates from clinical to commercial scale and is DEA-approved, with extensive experience in handling controlled substances (Schedule II–V).
The site offers a broad range of OSD manufacturing capabilities, including blending, milling, dry granulation, fluid bed drying, tablet compression (including bi- and tri-layer), encapsulation (powder and pellet filling), and advanced coating technologies such as film, column, and Wurster coating. The site also provides high-speed visual inspection and supports potent compound handling.
The facility integrates end-to-end packaging operations, including bottle filling, capping, heat sealing, labeling, serialization, and automated visual inspection, ensuring compliance with global regulatory requirements.
This site features extensive infrastructure, including a large warehouse with controlled temperature storage, cold storage (2–8°C), and dedicated controlled substances vaults. The site operates within a Foreign Trade Zone and is equipped to handle hazardous materials and large-scale commercial supply chains.
The site includes two analytical laboratories (main and high-containment) offering capabilities such as method transfer, validation, development, stability studies, and full QC testing using advanced instrumentation (HPLC/UPLC, GC, FT-IR, dissolution systems).
Additionally, the facility offers significant expansion potential through a pre-commissioned GMP facility (Module 8), providing approximately 50,000 sq. ft. of flexible manufacturing space that can be customized to meet future client and technology requirements.
With a strong regulatory track record, robust infrastructure, and deep expertise in controlled substances and commercial manufacturing, the site is positioned as a reliable partner for global pharmaceutical supply.
Compliance
- ICH
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- ANVISA (Brazil B-GMP)
- Roszdravnadzor (Russia GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- ICHQ3A
- ICHQ3B
- ICHQ3D
- ICHQ1A
- ICHM7
Activity
- Oral solids / OSD, Tablets, Hard capsules, Granules / Pellets, Powders, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING, Excipients manufacturing
Features
- Uses: Commercial (Phase IV), 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), TGA (Australia), ANVISA (Brazil), MFDS (South Korea), Russian Health Authorities
Batch Size / Reactor
- Medium, Large
Services
- Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Tech transfer, Formulation mixing, Engineering batches, Scale-up, Registration batches, Batch records, Analytical methods development, 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, Nitrosamine risk assessment, 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
Other plants of this company
FDF / DRUG PRODUCTS SERVICES in Europe Sterile fill-finish manufacturing site for injectable drug products (vials, ampoules, lyophilized), offering clinical-to-commercial supply with integrated quality, packaging, and analytical services.
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.
