Adare Pharma | US

Adare Pharma | US

Adare Pharma is a global CDMO with sites in US and EU providing turnkey product development through commercial manufacturing expertise focused on oral dosage forms for the Pharmaceutical, Animal...

About the plant

Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end services from product development through commercial manufacturing and packaging, with small molecule expertise focused on oral dosage forms.

 

Our specialized technology platforms deliver taste masking, customized release, solubility enhancement, and patient-centric dosing solutions. With decades of experience in drug delivery, Adare has developed and manufactured more than 65 products sold by customers worldwide.

 

In Europe, our Pessano, Italy facility recently completed a 2,800 square-meter extension that includes a purpose-built packaging hall housing a state-of-the-art Marchesini Integra 220S MA260 blister line. The line is designed for high-efficiency packaging of tablets and capsules into a wide range of formats, with an annual capacity of more than 50 million blisters. The new building also includes an expanded warehouse with capacity for over 900 pallets and infrastructure to support up to four more packaging lines. 

 

The expansion in Pessano complements our established US packaging capabilities, allowing us to provide our customers with integrated regional supply chains in both the US and Europe.

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• French Service-Public (CIR)
• ECOVADIS
• World Health Organization (GMP / HACCP)
• NMPA (China GMP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• MHRA (UK GMP)
• Halal Research Council
• UAE Ministry of Health & Prevention
• TITCK (Turkish Health Authorities)

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Activity

• Oral solids / OSD, Tablets, Hard capsules, Granules / Pellets, Powders, Gummies, FDF / DRUG PRODUCTS, SERVICES manufacturing

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Features

• Uses: 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: N/A
• BSL:
• Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support

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