首页

QUOTIENT SCIENCES LIMITED offer service "Commercial Manufacturing"

基本信息

385
10
6
4.4(20)

交易类型

提供服务

服务名称

Commercial Manufacturing

规格参数

  • Batch Size Range: 商业批量产能最高达500公斤,适用于口服固体制剂,在配备高活性化合物处理能力的费城工厂生产。
  • Regulatory Certifications CMO: 支持NDA、ANDA、MAA及JNDA注册生产,以及美国、英国、欧洲及日本的505(b)(2)及CBE-30申报。
  • Quality System: 提供工艺验证及注册批次生产专业能力,支持从III期供应到商业化上市的监管申报。

其他信息

补充描述:

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.
筛选:
排序方式:

    暂无评论。

匹配的产品和服务

基于贸易类型、类别、规格和价格范围的B2B匹配

相似产品和服务

与您正在查看的内容相关的产品和服务

其他人也浏览了

查看过此产品的人也浏览了其他产品和服务