Molecules / Orlistat

Orlistat API manufacturers

CAS 96829-58-2 ATC A08AB01 Updated 9 July 2026
10
manufacturers with an active filing 7 of them hold a US DMF or a CEP
$324.71
median export price per kg $225.17 to $486.86 · 27 exporters · 2025
4
shortage records on file across 2 countries
336
finished-dose makers across 40 regulators
Showing 10 of 10 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Biocon

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

Holds one active US DMF for orlistat, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

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

Divi's Laboratories

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

Holds one active US DMF for orlistat, filing since 2021. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Shandong New Time Pharmaceutical

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

Holds one active US DMF for orlistat, filing since 2015. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Formosa Laboratories

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Argus Pharmaceuticals

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

Holds one active US DMF for orlistat, filing since 2012.

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

Công ty TNHH BRV Healthcare

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for orlistat. 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
09

Công ty TNHH Liên Doanh Stellapharm - Chi nhánh 1

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for orlistat. 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
10

SaVipharm J.S.C

Vietnam
Makes the API

Registered with DAV (Vietnam) for orlistat. 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

7 more manufacturers hold filings for orlistat

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

Contract manufacturers (3)

Contract manufacturers make to order rather than holding their own filing for this molecule.

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
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Export price by year

Year Median Exporters
2025 $324.71 27
2024 $250.59 20
2023 $313.46 15
2022 $400.81 19

US dollars per kilogram, customs export unit values.