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
|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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