Home

QUOTIENT SCIENCES LIMITED offer service "Commercial Manufacturing"

Basic Information

385
10
6
4.4(20)

Trade Type

Offer Service

Service Name

Commercial Manufacturing

Specifications

  • Batch Size Range: Commercial batch capacity reaches up to 500 kg for solid oral dosage forms, manufactured at the Philadelphia facility equipped for high-potency compounds.
  • Regulatory Certifications CMO: Supports NDA, ANDA, MAA and JNDA registration manufacturing, plus 505(b)(2) and CBE-30 filings across the US, UK, Europe and Japan.
  • Quality System: Provides process validation and registration batch manufacturing expertise for regulatory submissions spanning Phase III supply through commercial launch.

Other Information

Additional Description:

Quotient Sciences is an established provider of commercial drug product manufacturing for small-molecule products in niche therapy areas such as oncology and orphan indications, with a Philadelphia facility equipped for high-potency compounds. Commercial batch capacity reaches up to 500 kg for solid oral dosage forms and up to 350 L for liquids via an automated filling line. Beyond NDA, ANDA, MAA and JNDA registration manufacturing, the team supports 505(b)(2) and CBE-30 filings, plus process validation and registration batches for regulatory submissions across the US, UK, Europe and Japan, along with Phase III and commercial supply and high-potency API handling.
Filters:
Sort by:

    No comments available.

Matched Products & Services

B2B matches based on trade type, category, specifications & price range

Similar Products & Services

Products & Services related to what you're viewing

People Also Viewed

Other products & services viewed by people who looked at this product