Darnytsia Kyiv

Darnytsia Kyiv

CMO combining advanced facilities, stringent quality control, and expert staff to deliver reliable, compliant, and innovative solutions for its clients.

About the plant

CMO offering state-of-the-art manufacturing and analytical facilities that ensure high-quality product  production. We maintain strict compliance with international regulatory standards, supported by advanced laboratories and cleanroom environments. With experienced staff and modern equipment, we provide reliable manufacturing services. We have production lines for the following dosage forms:

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Certifications

• ISO
• EMA (EU GMP)
• World Health Organization (GMP / HACCP)
• TGA (Australia GMP)

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Activity

• Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Oral solutions, Syrups, Tablets, Hard capsules, Powders, Lozenges, Bottles, Dropper bottles, BFS (Blow Fill Seal) ampolues, Large volume vials / Bottles, Glass ampoules, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
• Controlled substance: N/A
• BSL: N/A
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), EMA (EU), CDSCO (India), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), SFDA (Saudi Arabia), Turkish Health Authorities

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Tech transfer, Research batches, Engineering batches, Scale-up, Registration batches, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Batch certification / release, Primary packaging, Secondary packaging, Labeling, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission

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