Our pharmaceutical company in USA : Game-Changing Expansion
Our pharmaceutical company in the USA, based in Rochester, New York, handles the development of products from Phase I to III, generics, OTC, branded products, Class 2, 3, 4 and 5 Controlled Substances, and medical devices in the following dosage-forms:
- Blow-fill-seal (BFS lines running cGMP batches from 2016)
- Non-sterile liquids in pharmaceutical bottles and stick packs, with a special expertise in controlled release liquid products
- Tablets in bottles
- Multi-particulates in hard shell capsules
Our highly experienced R&D team assesses the early stage process and makes any necessary adaptations for pilot equipment and subsequent manufacturing under real industrial conditions.
Our pharmaceutical company in the USA boasts a dedicated 6,000 sq. ft. cGMP pilot workshop, enabling various non-sterile oral solid and liquid formulations to be manufactured for development, process scale-up, and clinical trials. For oral liquids, batch sizes range from 0.5 to 560 L.
For controlled release bead processes, GPCG-3 and GPCG-5 processors with Wurster inserts are available. Batch sizes in these units range from approximately 1 to 25 kg. For process scale-up and commercial manufacture, two GPCG-60 units are available with 18 and 32 inch Wurster inserts for batch sizes ranging from approximately 30 to 225 kg.
Our pharmaceutical company in the USA undertakes tableting and liquid stick-pack filling operations under industrial conditions. Tablet batch sizes can range from 1.5 to 75 kg with additional equipment available in commercial manufacturing for scale-up and commercialization.
The R&D teams at our pharmaceutical company in the USA are experienced, flexible, and able to adapt to a range of formulations and processes. They work diligently to meet all specified trial schedules and deadlines.