Molecules / Palbociclib

Palbociclib API manufacturers

CAS 571190-30-2 ATC L01XE33 Updated 9 July 2026
23
manufacturers with an active filing 21 of them hold a US DMF or a CEP
$5229.13
median export price per kg $4320.52 to $6903.82 · 15 exporters · 2025
1
shortage records on file across 1 countries
163
finished-dose makers across 46 regulators
Showing 20 of 23 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 for palbociclib, filing since 2018. 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
02

MSN Laboratories

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

Holds one active US DMF for palbociclib, filing since 2018. 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
03

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 palbociclib, filing since 2018. 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
View profile
04

Apotex

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

Holds one active US DMF for palbociclib, filing since 2018. 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
05

Macleods Pharmaceuticals

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

Holds one active US DMF for palbociclib, filing since 2026. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Alembic Pharmaceuticals

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

Holds one active US DMF for palbociclib, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

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

Synthon

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

Holds one active US DMF for palbociclib, filing since 2020. Its GMP is recognised in 14 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
14 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for palbociclib, filing since 2021. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Alivus Life Sciences

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

Holds 2 active US DMFs for palbociclib, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Shilpa Pharma Lifesciences

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

Holds one active US DMF for palbociclib, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Biophore India Pharmaceuticals

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

Holds one active US DMF for palbociclib, filing since 2018. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for palbociclib, filing since 2024. 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
13

Cdymax (India) Pharma

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

Holds one active US DMF for palbociclib, filing since 2018. 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
14

Chongqing Carelife Pharmaceutical

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

Holds one active US DMF for palbociclib, filing since 2022. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

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

Shandong Anhong Pharmaceutical

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

Holds one active US DMF for palbociclib, filing since 2018. 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
16

Aarti Pharmalabs

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

Holds one active US DMF for palbociclib, filing since 2025. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
17

ScinoPharm Taiwan

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

Holds one active US DMF for palbociclib, filing since 2018. 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
18
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for palbociclib, filing since 2022. 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
19

Matrix Pharmacorp

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

Holds one active US DMF for palbociclib, filing since 2017. 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
20

Pfizer Ireland Pharmaceuticals

Ireland
Makes the API

Registered with SFDA (Saudi Arabia) for palbociclib. 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

20 more manufacturers hold filings for palbociclib

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

ApotexMacleods PharmaceuticalsAlembic PharmaceuticalsSynthonLianyungang Runzhong PharmaceuticalAlivus Life SciencesShilpa Pharma LifesciencesBiophore India PharmaceuticalsZaklady Farmaceutyczne PolpharmaCdymax (India) PharmaChongqing Carelife PharmaceuticalShandong Anhong PharmaceuticalAarti PharmalabsScinoPharm TaiwanChunghwa Chemical Synthesis & BiotechMatrix PharmacorpPfizer Ireland Pharmaceuticals
Open the full list with a free account

Contract manufacturers (5)

Biophore India Pharmaceuticals India Mac Chem Products India India Chunghwa Chemical Synthesis & Biotech Taiwan Shanghai Haoyuan Chemexpress China Polpharma Group Poland

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (30)

Pfizer Brasil Ltda Brazil Pharmascience Canada Taro Pharmaceuticals Israel Pfizer United States Hospira United States Cipla India Pfizer Manufacturing Deutschland Germany Tuteur S A C I F I A Argentina Aizant Drug Research Solutions India Natco Pharma India Pfizer Canada Ulc Canada Pfizer Ireland Pharmaceuticals Unlimited Ireland Zydus Lifesciences India BDR Lifesciences India Incepta Pharmaceuticals Bangladesh Neolpharma Puerto Rico Aspen South Africa Laboratorio Elea Phoenix Argentina Pt. Tempo Scan Pacific Tbk Indonesia Laboratorio Lkm Argentina

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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Also on this molecule

Price history 4 yrs Shortages 1 Recalls 1 Finished dose 30 Contract mfrs 5

By country

India 19 China 6

Export price by year

Year Median Exporters
2025 $5229.13 15
2024 $6319.57 12
2023 $7899.50 14
2022 $8814.03 9

US dollars per kilogram, customs export unit values.