Metformin Hydrochloride
制剂 FDF · 薄膜包衣片 / 缓释片 · 500 mg / 850 mg / 1000 mg
制剂 FDFCEPUS DMF IIConfidentiality：公开
- INN / Generic Name
- Metformin Hydrochloride
- Dosage Form
- 薄膜包衣片 / 缓释片
- Strength
- 500 mg / 850 mg / 1000 mg
- Therapy Area
- 内分泌（代谢）
- Indication
- 2 型糖尿病
- Current Status
- 已上市（全球多市场，CEP 齐备）
- GMP Certification
- EU GMP
- CEP
- Yes
- DMF Type
- US DMF II
- Stability Data
- 60 months
- BE Required
- Not required / waivable
- Registration Pathway
- DCP / NP（CEP 支撑，BE 可豁免）
- MOQ
- 100 万片
- Lead Time
- 40 天
- Price Range
- US$ 6-12 / 千片
Registrable Markets
Saudi ArabiaMoroccoVietnamBrazilPeru
Process / Sequence / Exact Price
- Process Summary
- 湿法制粒 + 薄膜包衣（公开工艺简述）
- Exact Price
- US$ 8.4 / 千片