Molecules / Zoledronic Acid

Zoledronic Acid API manufacturers

CAS 118072-93-8 ATC M05BA08 Updated 9 July 2026
18
manufacturers with an active filing 13 of them hold a US DMF or a CEP
41
shortage records on file across 5 countries
602
finished-dose makers across 48 regulators
Showing 18 of 18 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

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 zoledronic acid, filing since 2011. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
02

USV

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

Holds one active US DMF and one valid CEP for zoledronic acid, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
9 markets
05

Dr. Reddy's Laboratories

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

Holds one valid CEP for zoledronic acid, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced EDQM certificate database
View profile
06

Natco Pharma

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

Holds 2 active US DMFs for zoledronic acid, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

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

Gador S A

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

Holds one active US DMF for zoledronic acid, filing since 2009. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
8 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for zoledronic acid, filing since 2010. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Maprimed

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

Holds one active US DMF for zoledronic acid, filing since 2012. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

ScinoPharm Taiwan

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

Holds one active US DMF for zoledronic acid, filing since 2009. 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
11

Trifarma

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

Holds one active US DMF for zoledronic acid, filing since 2013. 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
12

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for zoledronic acid, filing since 2006. Its 2022 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Pharmaceutical Works Polpharma

Poland
Makes the API

Registered with SFDA (Saudi Arabia) for zoledronic acid. Its GMP is recognised in 10 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
10 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
14

Cipla

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for zoledronic acid. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
15

Yung Shin Pharmaceutical Ind

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

Holds one active US DMF for zoledronic acid, filing since 2012. Its GMP is recognised in 1 market.

US DMF
1 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
16

MN Pharmaceuticals

Turkey
Makes the API

Registered with SFDA (Saudi Arabia) for zoledronic acid.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for zoledronic acid. 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
18

Công ty cổ phần Dược phẩm An Thiên

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for zoledronic acid. 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

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