Commercial Manufacturing

Product description

Quotient Sciences is a global player in commercial drug product manufacture of small molecule products for niche therapies including oncology and orphan drugs. Our commercial manufacturing facility located in Philadelphia is designed to handle your high-potency compounds.
Our commercial batch size capabilities include: - Up to 500kg for solid oral dosage forms
- Up to 350L for liquid formats using an automated filling line. In addition to manufacturing products for NDA, ANDA, MAA and JNDA registration, the Quotient team can support 505(b)(2) and CBE-30 filings.

Process validation and registration batches: Whether you are preparing for NDA, MAA or Japanese NDA, Quotient has the expertise and regulatory approval to manufacture your validation and registration batches for the U.S., U.K., Europe and Japan.

- Phase III and commercial drug product supply
- High potency API handling 



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Specifications

Categories Contract Services - Contract ServicesContract Manufacturing; Custom ManufacturingCustom Manufacturing (general category); Finished Dosage Forms
Sales markets Oceania; North America (USA, Canada); East Asia (e.g. China, Japan, Korea); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South Asia (e.g. India, Pakistan, Sri Lanka); South East Asia (e.g. Thailand, Philippines, Singapore)
Supplied from United Kingdom; United States

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