Molecules / Pimecrolimus

Pimecrolimus API manufacturers

CAS 137071-32-0 ATC D11AH02 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
6
shortage records on file across 2 countries
66
finished-dose makers across 32 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Biocon

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

Holds one active US DMF for pimecrolimus, filing since 2015. 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
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02

Concord Biotech

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

Holds one active US DMF for pimecrolimus, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

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

Medichem

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

Holds one active US DMF for pimecrolimus, filing since 2015. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

BrightGene Bio-Medical Technology

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

Holds 2 active US DMFs for pimecrolimus, filing since 2015. Its GMP is recognised in 1 market.

US DMF
2 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
05

Chengdu Yacht Biotechnology

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

Holds one active US DMF for pimecrolimus, filing since 2025.

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
06

Curia

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

Holds one active US DMF for pimecrolimus, filing since 2017.

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

3 more manufacturers hold filings for pimecrolimus

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

BrightGene Bio-Medical TechnologyChengdu Yacht BiotechnologyCuria
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Finished-dose makers (6)

Glenmark Pharmaceuticals s.r.o Czech Republic Teva Israel Viatris United States Novartis Pharma Produktions Germany MEDA MANUFACTURING GmbH Germany Menarini Indria Laboratories Indonesia

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

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Also on this molecule

Shortages 6 Recalls 1 Finished dose 6 Contract mfrs 0