Molecules / Amlodipine / India

Amlodipine API manufacturers in India

CAS 88150-42-9 ATC C08CA01 Updated 9 July 2026
27
India-based manufacturers with an active filing of 43 worldwide
$79.34
median export price per kg, all origins $45.14 to $153.10 · 125 exporters · 2025
Showing 15 of 27 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Dr. Reddy's Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF and one valid CEP for amlodipine, filing since 2003. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
02

Cadila Pharmaceuticals

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF and one valid CEP for amlodipine, filing since 2003. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
15 markets
04

Zydus Lifesciences

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs and one valid CEP for amlodipine, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
05

Hetero

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for amlodipine, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Ipca Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for amlodipine, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Lupin

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for amlodipine, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Lee Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for amlodipine, filing since 2026. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Alkem Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for amlodipine, filing since 2015. Its GMP is recognised in 21 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
21 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Unichem Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for amlodipine, filing since 2024. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2026 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
View profile
11

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF and one valid CEP for amlodipine, filing since 2005. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Srini Pharmaceuticals

India
Makes the API

Holds one active US DMF for amlodipine, filing since 2009. Its 2019 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Orbion Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for amlodipine, filing since 2006.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Arch Pharmalabs

India
Makes the API

Holds one active US DMF for amlodipine, filing since 2010. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

12 more manufacturers in India hold filings for amlodipine

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Open the full list with a free account

How this list is built

This page filters the worldwide Amlodipine manufacturer list to companies based in India. The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Read the full method.

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