Pharmaron Coventry Site (US)

Pharmaron Coventry Site (US)

Small Molecule (RSM/APIs) Commercial Facility

About the plant

50L to 8,000L reactors Controlled substances DEA Schedule I to Schedule V.

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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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