Metformin Hydrochloride
Formulation (FDF) · Film-coated tablets / sustained-release tablets · 500 mg / 850 mg / 1000 mg
Formulation (FDF)CEPUS DMF IIConfidentiality：Public
- INN / Generic Name
- Metformin Hydrochloride
- Dosage Form
- Film-coated tablets / sustained-release tablets
- Strength
- 500 mg / 850 mg / 1000 mg
- Therapy Area
- Endocrine / Metabolic
- Indication
- Type 2 diabetes mellitus
- Current Status
- Marketed (multiple global markets, CEP in place)
- 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-supported, BE waivable)
- MOQ
- 1,000,000 tablets
- Lead Time
- 40 days
- Price Range
- US$ 6-12 / 1k tablets
HS Code
3004.903 customs bills on file
Registrable Markets
Saudi ArabiaMoroccoVietnamBrazilPeru
Process / Sequence / Exact Price
- Process Summary
- Wet granulation + film coating (public process summary)
- Exact Price
- US$ 8.4 / 1k tablets