Molecules / Alendronic Acid

Alendronic Acid API manufacturers

CAS 66376-36-1 ATC M05BA04 Updated 9 July 2026
11
manufacturers with an active filing 10 of them hold a US DMF or a CEP
$150.00
median export price per kg $101.73 to $250.00 · 14 exporters · 2025
2
shortage records on file across 2 countries
650
finished-dose makers across 44 regulators
Showing 11 of 11 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 for alendronic acid, filing since 2006. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

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

Apotex

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

Holds one active US DMF for alendronic acid, filing since 2001. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

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

Ipca Laboratories

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

Holds one active US DMF for alendronic acid, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

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

Cipla

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

Holds one active US DMF for alendronic acid, filing since 1999. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Orchid Pharma

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

Holds one active US DMF for alendronic acid, filing since 2007. 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
06

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for alendronic acid, filing since 2003. 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
07

Apitoria Pharma

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

Holds one active US DMF for alendronic acid, filing since 2006. Its 2025 FDA inspection closed as VAI.

US DMF
1 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
08

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for alendronic acid, filing since 2009. 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
09

Matrix Pharmacorp

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

Holds one active US DMF for alendronic acid, filing since 2007. Its 2025 FDA inspection closed as VAI.

US DMF
1 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
10
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for alendronic acid, filing since 2012. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Aurobindo Pharma

India
Makes the API

Registered with SFDA (Saudi Arabia) for alendronic acid. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 21 markets.

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

8 more manufacturers hold filings for alendronic acid

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

CiplaOrchid PharmaZaklady Farmaceutyczne PolpharmaApitoria PharmaJubilant BiosysMatrix PharmacorpMinsheng Group Shaoxing PharmaceuticalAurobindo Pharma
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Finished-dose makers (104)

HIKMA ITALIA Italy Pharmascience Canada Amneal Pharmaceuticals of New York United States Zentiva, k.s Czech Republic Viatris United States Teva Israel Sandoz Switzerland ANI Pharmaceuticals United States Organon Pharma (Uk) United Kingdom Pfizer Brasil Ltda Brazil Towa Pharmaceutical Europe, S.L Spain Eurofarma Laboratorios Brazil Hangzhou Minsheng Binjiang Pharmaceutical China Inmenol Industrial Laboratorios Dominican Republic Jamp Pharma Canada Laboratoire Riva Canada Macleods Pharmaceuticals India Casen Recordati, S.L Spain Laboratorios Cinfa S A Spain Laboratorios Normon Spain

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.

Who makes alendronic acid?

Ask Fred which manufacturers are on record for alendronic acid and what filings they hold.

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Also on this molecule

Price history 4 yrs Shortages 2 Finished dose 104 Contract mfrs 0

By country

India 8

Export price by year

Year Median Exporters
2025 $150.00 14
2024 $138.50 15
2023 $165.23 19
2022 $187.39 20

US dollars per kilogram, customs export unit values.