Molecules / Cilastatin

Cilastatin API manufacturers

CAS 82009-34-5 Updated 9 July 2026
7
manufacturers with an active filing 5 of them hold a US DMF or a CEP
10
shortage records on file across 6 countries
198
finished-dose makers across 31 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Acs Dobfar

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

Holds 4 active US DMFs for cilastatin, filing since 2008. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 12 markets.

US DMF
4 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
12 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Savior Lifetec

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

Holds one active US DMF for cilastatin, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

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

Unimark Remedies

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

Holds 2 active US DMFs for cilastatin, filing since 2014. Its GMP is recognised in 5 markets.

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

JW Pharmaceutical

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

Holds one active US DMF for cilastatin, filing since 2009. Its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Merck Sharp & Dohme

United States
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for cilastatin. Its GMP is recognised in 16 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
16 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
07

Orchid Pharma

India
Makes the API

Registered with SFDA (Saudi Arabia) for cilastatin. Its GMP is recognised in 3 markets.

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

4 more manufacturers hold filings for cilastatin

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 (2)

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

Map cilastatin 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.

Sold in these combinations

Fixed-dose combinations containing cilastatin. Each page leads with the verified API makers of every component.