The FDA approves remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
|Articles|February 25, 2020
Know-How to Deliver Your Product
Author(s)Pii
Pii brings 25 years of scientific and regulatory know-how to the development of your liquid and lyophilized sterile, semi-solid, and oral solid dose drug product, including expanded sterile fill-finish capacity.
With 25 years of experience and exceptional know-how within our team, Pii is a CDMO that supports customers in product development and clinical to commercial-scale manufacture across a range of dosage forms, including liquid and lyophilized steriles and challenging liquid, semi-solid and oral solids, including potents, hormones, and controlled substances.
Our capabilities in aseptic fill-finish have been expanded and strengthened with the installation and validation of a fully-robotic filling line, offering greater capacity, efficiency, and flexibility in bringing sterile products to market.
With experience and integrity in our leadership team and across our operations, we bring total commitment to your product and your needs, and a pledge of quality, reliability, transparency, and responsiveness. We have the track record and knowledge to navigate the regulatory filing process, and can assure you that nothing is more important to us than our relationship with you and your product’s success.
Dosage Forms
- Parenterals
- Sterile Liquids
- Oral Solid Dose
- Tablets
- Capsules
- Soft Gels
- High-Potent Drugs
- Controlled Substances (Schedules I – V)
- Hormones
- Cytotoxics
Services
- Pre-Formulation Studies
- Dosage Form Development & Manufacturing
- Analytical Development & Testing
- CTM & Commercial Manufacturing
- Serialization
- Clinical Packaging & Distribution
- Regulatory Support
- Quality Management
- Commercial Packaging
Pii
10819 Gilroy Road
Hunt Valley, Maryland 21031, USA
tel. +1.410.584.0001
bd@pharm-int.com
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