Molecules / Ondansetron / India

Ondansetron API manufacturers in India

CAS 99614-02-5 ATC A04AA01 Updated 9 July 2026
21
India-based manufacturers with an active filing of 24 worldwide
$610.00
median export price per kg, all origins $200.00 to $1200.00 · 52 exporters · 2025
Showing 12 of 21 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 2 active US DMFs and one valid CEP for ondansetron, filing since 2001. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
2 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 ondansetron, 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
03

Ipca Laboratories

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

Holds 2 active US DMFs and 2 valid CEPs for ondansetron, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
2 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
04

Cipla

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

Holds one active US DMF and 4 valid CEPs for ondansetron, filing since 2001. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

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

Natco Pharma

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

Holds 4 active US DMFs and one valid CEP for ondansetron, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
4 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
06

SMS Pharmaceuticals

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

Holds one active US DMF and one valid CEP for ondansetron, filing since 2008. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
6 markets
07

Apitoria Pharma

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

Holds one active US DMF and 2 valid CEPs for ondansetron, filing since 2005. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Alivus Life Sciences

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

Holds 2 active US DMFs for ondansetron, filing since 2026. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

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

Symed Labs

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

Holds one valid CEP for ondansetron, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
10

Hikal

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

Holds 2 active US DMFs and one valid CEP for ondansetron, filing since 2003. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
2 markets
11

Shodhana Laboratories

India
Makes the API

Registered with SFDA (Saudi Arabia) for ondansetron. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
12

Therapiva

India
Makes the API

Registered with SFDA (Saudi Arabia) for ondansetron. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

9 more manufacturers in India hold filings for ondansetron

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 Ondansetron 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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