Molecules / Hydroxyzine / India

Hydroxyzine API manufacturers in India

CAS 68-88-2 ATC N05BB01 Updated 9 July 2026
13
India-based manufacturers with an active filing of 10 worldwide
$137.50
median export price per kg, all origins $84.00 to $169.21 · 16 exporters · 2025
Showing 8 of 13 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

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 hydroxyzine, filing since 2010. 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
02

Symed Labs

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

Holds 4 active US DMFs and one valid CEP for hydroxyzine, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
4 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
03

Cohance Lifesciences

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

Holds 2 active US DMFs for hydroxyzine, filing since 2025. 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
04

Glochem Industries

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

Holds 2 active US DMFs for hydroxyzine, filing since 2022. Its 2024 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Kreative Organics

India
Makes the API

Holds one valid CEP for hydroxyzine, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
06

Srikem Laboratories

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

Holds one active US DMF for hydroxyzine, filing since 2014. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Mahi Drugs

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

Holds one active US DMF for hydroxyzine, filing since 2023.

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
08
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for hydroxyzine, filing since 2010. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · OAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile

5 more manufacturers in India hold filings for hydroxyzine

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 Hydroxyzine 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.

Map hydroxyzine for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

All Hydroxyzine manufacturers