FDF / DRUG PRODUCTS SERVICES in APAC
The Nanjing site specializes in the development and production of solid and liquid pharmaceutical forms, both sterile and non-sterile.
About the plant
The Nanjing manufacturing site of Unither Pharmaceuticals is located in Jiangsu Province, China, and forms part of the group’s global network of contract development and manufacturing organizations (CDMOs). The facility specializes in the development and production of pharmaceutical products in both solid and liquid dosage forms, including sterile formulations.
The site has strong expertise in sterile single-dose liquid products manufactured using Blow-Fill-Seal (BFS) technology. This aseptic process integrates container forming, filling, and sealing in a single operation and is widely used for ophthalmic and respiratory solutions requiring high sterility assurance. The Nanjing facility focuses particularly on ophthalmology and ENT products, supplying pharmaceutical companies in China and supporting access to international markets.
In addition to sterile liquid manufacturing, the plant also supports solid dosage forms and provides development services such as formulation development, process optimization, and analytical quality control testing. Operating under Chinese GMP regulations and aligned with international pharmaceutical quality standards, the Nanjing facility plays a strategic role in Unither’s expansion in Asia and in supplying safe, high-quality pharmaceutical products to regional and global healthcare markets.
Compliance
- EMA (EU GMP)
- FDA (cGMP)
- NMPA (China GMP)
Activity
- Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Granules / Pellets, Fill&Finish, BFS (Blow Fill Seal) ampoules, FDF / DRUG PRODUCTS, SERVICES manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): N/A
- Controlled substance: Lowest potential for abuse
- BSL: N/A
- Therapeutic areas: (R) Respiratory system, (S) Sensory organs
- Markets: FDA (USA), EMA (EU), NMPA (China)
Batch Size / Reactor
- Medium, Large
Services
- Development services, Manufacturing services, Analytical / QC services, Formulation / Galenic design, Process development, Process optimization, Stability studies design, Tech transfer, Pilot plant, Formulation mixing, Scale-up, Batch records, Analytical methods development, Analytical methods validation, Stability tests, Identity, Content, Purity / Potency, Drug Product – Liquid, Drug Product – Solid, API / Excipient – Liquid, API / Excipient – Solid
Other plants of this company
FDF / DRUG PRODUCTS SERVICES in North America CDMO specializing in sterile unit-dose liquid drug products using Blow-Fill-Seal (BFS) technology for ophthalmic, nasal and inhalation therapies.
FDF / DRUG PRODUCTS NUTRACEUTICALS SERVICES in LATAM The Barretos site specializes in the manufacturing of liquid and solid forms for the pharmaceutical and nutraceutical markets.
FDF / DRUG PRODUCTS SERVICES in Europe Make affordable healthcare solutions that improve and simplify patients lives
