Pharmaron API Commercial Synthesis Coventry (US)

Pharmaron API Commercial Synthesis Coventry (US)

Commercial API Small Molecules Synthesis

About the plant

The Pharmaron Coventry site, located in Rhode Island, USA, was acquired by Pharmaron in 2022, further strengthening the company’s technological capabilities and service offerings.

Coventry is an FDA-approved facility equipped with reactors ranging from 50 L to 8,000 L, enabling batch production from just a few grams to several hundred kilograms. The site supports the full development lifecycle—from clinical phases through to commercial manufacturing.

The facility is organized into a PR&D/pilot plant building and a commercial-scale production building, with a combined reactor capacity of 76,000 L.

Coventry stands out for its large-scale hydrogenation capabilities and is DEA-approved to manufacture controlled substances across Schedules I to V.

The site also plays a key role in Pharmaron’s successful hybrid China–US model: advanced intermediates are produced in China, shipped to Coventry, and converted into final APIs in the US. This model ensures a robust, flexible supply chain while maintaining cost-efficiency (COGs).

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Certifications

• ISO
• FDA (cGMP)
• ECOVADIS

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Activity

• CHEMICAL-SYNTHETIC, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients) manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• 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)
• DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL:
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
• Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), MFDS (South Korea)

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Batch Size / Reactor

• Small, Medium, Large, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L

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Services

• Development services, Manufacturing services, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Co-crystal screening, Crystallization screening, Chiral resolution screening, Milling, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment

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