At Formurex, we understand that drug development is complex and highly regulated. Whether you’re in early discovery or preparing for clinical trials, our team is here to support you with clarity, precision, and proven expertise. Below are answers to some of the most common questions we receive.
What types of dosage forms does Formurex specialize in?
Formurex supports a wide range of dosage forms, including oral solids (tablets, capsules), oral liquids (solutions, suspensions), topicals (creams, gels, ointments), ophthalmics, and specialty delivery systems such as transdermals, sublinguals, and drug-device combinations.
Can Formurex handle controlled and potent substances?
Yes. We are licensed and equipped to work with controlled substances (Class II to Class V) as well as highly potent compounds, following strict regulatory and safety protocols.
Do you offer support for preclinical and clinical formulation development?
Absolutely. We offer customized preclinical formulations for PK/PD, tox, and efficacy studies, along with clinical formulation development for Phase 1 and beyond.
What analytical services do you provide?
Formurex offers full-spectrum analytical services including method development, validation, raw material and finished product testing, stability studies, extractables and leachables, cleaning validation, and more—all per ICH/USP guidelines.
How does Formurex ensure GMP compliance in manufacturing?
Our manufacturing facility operates under strict GMP guidelines, with a robust quality management system and 24/7 environmental monitoring. QA oversight is integrated into every step of the process.
Can Formurex support regulatory submissions?
Yes. We assist sponsors in preparing and submitting regulatory dossiers, including IND, IMPD, NDA, MAA, and ANDA, ensuring your data packages meet global requirements.
What is your manufacturing capacity for clinical trial materials?
Formurex can produce up to 10,000 tablets or 5,000 capsules per day, supporting small- to mid-scale clinical supply needs with precision and flexibility.
Still Have Questions?
Let’s talk! Contact our team today, and we’ll be happy to provide the answers and support you need to move forward with confidence.