Unither Pharmaceuticals

Unither Pharmaceuticals

make affordable healthcare solutions that improve and simplify patients lives

About the plant

With nearly 30 years of experience and constant innovation, French pharmaceutical company Unither has established itself as a world leading contract development and manufacturing organization of pharmaceutical products. At our sited in France, US, Brazil and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing needs. 

 

We specialize in unit dose manufacturing and our expertise includes an extensive range of unit dose packaging, such as Blow-Fill-Seal (BFS),  In addition, we also manufacture preservative-free multidose, pharmaceutical bottles, sprays, tablets, tubes, suppositories and pessaries.  Production lines in France, the USA and Brazil are regularly inspected by their regulatory authorities to ensure our products’ compliance and processes.   

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• French Service-Public (CIR)
• ECOVADIS
• NMPA (China GMP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• MFDS/KFDA (Republic of Korea GMP)
• COFEPRIS
• MHRA (UK GMP)
• SFDA (Saudi Food & Drug Authority)
• TITCK (Turkish Health Authorities)

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Activity

• Inhalation products, Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Bottles, Sprays, Sachets, Stick packs, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Oral gels, Tablets, Hard capsules, Fill&Finish, BFS (Blow Fill Seal) ampoules, Bottles, Dropper bottles, Ophtalmic dispensers, Sprays, Liquid forms, Suppositories and vaginal ovules, tablets, capsules, rings, Fill&Finish, BFS (Blow Fill Seal) ampolues, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), FDF / DRUG PRODUCTS, SERVICES manufacturing

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Features

• Uses: Commercial (Phase IV), Human
• Toxicity (OEB classification): N/A
• DEA: Schedule II (high potential for abuse / medical use)
• BSL: 1, 2
• Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (R) Respiratory system
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

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Batch Size / Reactor

• Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of product, Analytical methods transfer, Batch certification / release, Primary packaging, Secondary packaging, Labeling, Serialization, CMC regulatory support

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