Molecules / Nateglinide

Nateglinide API manufacturers

CAS 105816-04-4 ATC A10BX03 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
43
finished-dose makers across 17 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Cadila Pharmaceuticals

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

Holds one active US DMF for nateglinide, filing since 2013. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Synthimed Labs

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

Holds 2 active US DMFs for nateglinide, filing since 2007. Its 2020 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2020 · NAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Dr. Reddy's Laboratories

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

Holds one active US DMF for nateglinide, filing since 2004. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

USV

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

Holds one active US DMF for nateglinide, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Unichem Laboratories

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

Holds one valid CEP for nateglinide, 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
06

Zydus Lifesciences

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

Holds one active US DMF for nateglinide, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

3 more manufacturers hold filings for nateglinide

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

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. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

Map nateglinide 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.

Also on this molecule

By country