Amlodipine Besylate
Formulation (FDF) · Tablets · 5 mg / 10 mg
Formulation (FDF)CEPUS DMF IIConfidentiality：Public
- INN / Generic Name
- Amlodipine Besylate
- Dosage Form
- Tablets
- Strength
- 5 mg / 10 mg
- Therapy Area
- Cardiovascular
- Indication
- Hypertension / coronary heart disease
- Current Status
- Marketed (China + 3 Latin American markets)
- GMP Certification
- EU GMP
- CEP
- Yes
- DMF Type
- US DMF II
- Stability Data
- 48 months
- BE Required
- Yes
- Registration Pathway
- ANDA / NP
- MOQ
- 500,000 tablets
- Lead Time
- 40 days
- Price Range
- US$ 9-16 / 1k tablets
HS Code
3004.903 customs bills on file
Registrable Markets
BrazilPeruColombia
Process / Sequence / Exact Price
- Process Summary
- Direct compression (public summary)
- Exact Price
- US$ 12.0 / 1k tablets