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百悦达 - NMPA Drug Approval Details

Approvals/NMPA/Sonrotoclax Tablets

Approved

化学药品

Sonrotoclax Tablets

百济神州（苏州）生物科技有限公司🇨🇳 National Medical Products Administration

Approval Date: Feb 11, 2026
Approval ID: 8mdl4eNs1j3
Company: 百济神州（苏州）生物科技有限公司
Type: 化学药品

Approval Details

Approval Id: 8mdl4eNs1j3
Approval Number: 国药准字H20250076
Generic Name: 索托克拉片
Generic Name En: Sonrotoclax Tablets
Trade Name: 百悦达
Drug Type: 化学药品
Dosage Form: 片剂
Strength: 5mg
Reg Date: 2026-02-11
Company Name: 百济神州（苏州）生物科技有限公司
Company Address: 中国（江苏）自由贸易试验区苏州片区苏州工业园区金海路29号
Production Company Name: 常州合全药业有限公司（生产索托克拉固体分散体）；百济神州（苏州）生物科技有限公司（生产索托克拉片）
Production Company Address: 常州市新北区玉龙北路589号（生产索托克拉固体分散体）；中国（江苏）自由贸易试验区苏州片区苏州工业园区桑田街218号生物产业园9栋（生产索托克拉片）
Company Detail Path: /organization/a95544bc28afaf6e/bai-ji-shen-zhou-su-zhou-sheng-wu-ke-ji-you-xian-gong-si

Approved

Quick Info

Agency

NMPA

Country

🇨🇳

Approval Date

Feb 11, 2026

Approval ID

8mdl4eNs1j3

Type

化学药品

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