Molecules / Gemcitabine

Gemcitabine API manufacturers

CAS 95058-81-4 ATC L01BC05 Updated 9 July 2026
16
manufacturers with an active filing 13 of them hold a US DMF or a CEP
$3171.43
median export price per kg $2748.78 to $3457.61 · 12 exporters · 2025
28
shortage records on file across 5 countries
513
finished-dose makers across 51 regulators
Showing 16 of 16 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF and one valid CEP for gemcitabine, filing since 2005. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
06

MSN Laboratories

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

Holds one active US DMF for gemcitabine, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

ScinoPharm Taiwan

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

Holds one active US DMF for gemcitabine, filing since 2005. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Ravi Biolife

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

Holds one active US DMF and one valid CEP for gemcitabine, filing since 2024. Its GMP is recognised in 2 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
2 markets
09

Fresenius Kabi Ab

Sweden
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for gemcitabine. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
48 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
10

Eli Lilly And

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

Holds one valid CEP for gemcitabine, filing since 2014. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2026 · VAI
GMP recognised in
40 markets
How this listing is sourced EDQM certificate database
View profile
11

Farmhispania

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

Holds one active US DMF for gemcitabine, filing since 2024. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Arch Pharmalabs

India
Makes the API

Holds 2 active US DMFs for gemcitabine, filing since 2010. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Gland Pharma

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

Holds one active US DMF for gemcitabine, 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
15

Maithri Drugs

India
Makes the API

Registered with SFDA (Saudi Arabia) for gemcitabine. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
16

Bidiphar - Dược Bình Định

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for gemcitabine. 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

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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By country

Export price by year

Year Median Exporters
2025 $3171.43 12
2024 $3157.22 12
2023 $3000.00 17
2022 $3525.72 9

US dollars per kilogram, customs export unit values.