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List of Drug Master Files (DMF) of Linezolid Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Linezolid
CAS 168828-90-8
CAS 212325-40-1
168828-84-0
CAS 174649-09-3
CAS 858344-36-2
CAS 168828-82-8
CAS 168828-81-7
USDMF

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Linezolid

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

72 API Suppliers, 30 USDMF, 5 JDMF, 20 EU WC, 7 KDMF, 19 NDC API, 48 Listed Suppliers, $ API Reference Price

72 API Suppliers
30 USDMF
5 JDMF
20 EU WC
7 KDMF
19 NDC API
48 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

20 API Suppliers

20 API Suppliers

FINISHED DOSAGE FORMULATIONS

185 FDF Dossiers, 35 FDA Orange Book, 62 Europe, 7 Canada, 21 South Africa, 60 Listed Dossiers

185 FDF Dossiers
35 FDA Orange Book
62 Europe
7 Canada
21 South Africa
60 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 600MG, SOLUTION;INTRAVENOUS - 200MG/100ML (2MG/ML), SOLUTION;INTRAVENOUS - 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - 600MG/300ML (2MG/ML)

TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 600MG
SOLUTION;INTRAVENOUS - 200MG/100ML (2MG/ML)
SOLUTION;INTRAVENOUS - 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - 600MG/300ML (2MG/ML)

RELATED EXCIPIENT COMPANIES

1 Minakem, 4 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 6 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 9 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 2 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Doshion Polyscience, 1 Finar, 8 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 31 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

99 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 51 Direct Compression, 49 Disintegrants & Superdisintegrants, 36 Thickeners and Stabilizers, 34 Granulation, 34 Controlled & Modified Release, 26 Taste Masking, 23 Lubricants & Glidants, 20 Solubilizers, 20 Chewable & Orodispersible Aids, 19 Film Formers & Plasticizers, 18 Co-Processed Excipients, 17 Parenteral, 13 Topical, 9 Rheology Modifiers, 6 API Stability Enhancers, 5 Empty Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 4 Vegetarian Capsules, 2 Surfactant & Foaming Agents

99 Fillers, Diluents & Binders
53 Coating Systems & Additives
51 Direct Compression
49 Disintegrants & Superdisintegrants
36 Thickeners and Stabilizers
34 Granulation
34 Controlled & Modified Release
26 Taste Masking
23 Lubricants & Glidants
20 Solubilizers
20 Chewable & Orodispersible Aids
19 Film Formers & Plasticizers
18 Co-Processed Excipients
17 Parenteral
13 Topical
9 Rheology Modifiers
6 API Stability Enhancers
5 Empty Capsules
4 Coloring Agents
4 Emulsifying Agents
4 Vegetarian Capsules
2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 43 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
43 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 40 Finished Drug Prices, 8 Annual Reports

3 US Medicaid Prescriptions
40 Finished Drug Prices
8 Annual Reports

MARKET PLACE

43 APIs, 20 FDF Dossiers

43 APIs
20 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 15 Others

1 USP
15 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 798 Xls

Filters

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Filters

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30 All

01 2Neuland Laboratories

02 3Alembic Pharmaceuticals Limited

03 2Amoli Organics

04 1Apotex Pharmachem

05 1Chongqing Huapont Pharmaceutical

06 1Chromo Laboratories

07 1Formosa Laboratories

08 1GLAND PHARMA LIMITED

09 2Glenmark Life Sciences

10 1Grace

11 1Jubilant Generics

12 1LACAMAS LABORATORIES INC

13 1Lee Pharma

14 1Macleods Pharmaceuticals Limited

15 1Optimus Pharma

16 1Raks Pharma

17 2Symed Labs

18 1Teva API

19 1UQUIFA

20 1Zhejiang Hisun Pharmaceutical

21 1Zhejiang Medicine Co Ltd

22 1Zhejiang Neo-Dankong Pharm. Co.,Ltd.

23 1Zhejiang Supor Pharmaceuticals Co., LTD

24 1Zydus Lifesciences

filter Subject Reset all filters

30 All

01 11LZD-LINEZOLID, STEP 1

02 11LZD-LINEZOLID, STEP 1 (1LZD)

03 12LINEZOLID

04 1LINEZOLID (FORM I), NON-STERILE BULK DRUG SUBSTANCE

05 1LINEZOLID (FORM III)

06 1LINEZOLID (FORM-II)

07 1LINEZOLID D111 PROCESS

08 1LINEZOLID FORM 1

09 4LINEZOLID USP

10 1LINEZOLID USP (FORM-I)

11 2LINEZOLID USP (FORM-II)

12 1LINEZOLID USP (NON-STERILE API)

13 1LINEZOLID USP (PROCESS-II)

14 1LINEZOLID [FORM-1]

15 1LINEZOLID [FORM-II]

filter Country Reset all filters

30 All

01 1Canada

02 5China

03 19India

04 1Israel

05 1Spain

06 1Taiwan

07 2U.S.A

filter Status Reset all filters

30 All

01 25Active

02 5Inactive

filter GDUFA DMF Review Reset all filters

30 All

01 16Complete

02 14Blank

API Suppliers
USDMF
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Neuland Laboratories Ltd

CPhI Worldwide, Milan

Neuland Laboratories- A dedicated 100% API provider.

Contact Supplier

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Digital Content

Linezolid Usp (form-ii)

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-27

Pay. Date : 2014-06-23

DMF Number : 24506

Submission : 2010-12-29

Status : Active

Type : II

Product Web Link

Digital Content

02

Neuland Laboratories Ltd

CPhI Worldwide, Milan

Neuland Laboratories- A dedicated 100% API provider.

Contact Supplier

Contact Supplier

Digital Content

Linezolid Usp (process-ii)

GDUFA

DMF Review : Complete

Rev. Date : 2024-02-21

Pay. Date : 2024-01-23

DMF Number : 36946

Submission : 2022-03-31

Status : Active

Type : II

Product Web Link

Digital Content

03

Alembic Pharmaceuticals Ltd

USDMF

FNCE 2024

Not Confirmed

03

Alembic Pharmaceuticals Ltd

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

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Digital Content

Linezolid Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-06

Pay. Date : 2012-12-21

DMF Number : 24790

Submission : 2011-03-25

Status : Active

Type : II

Product Web Link

Digital Content

04

Formosa Laboratories Inc

USDMF

FNCE 2024

Not Confirmed

04

Formosa Laboratories Inc

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-10

Pay. Date : 2013-03-01

DMF Number : 25700

Submission : 2012-01-09

Status : Active

Type : II

Product Web Link

Digital Content

05

Glenmark Life Sciences Ltd

USDMF

FNCE 2024

Not Confirmed

05

Glenmark Life Sciences Ltd

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19746

Submission : 2006-09-11

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Jubilant Pharmova Ltd

USDMF

FNCE 2024

Not Confirmed

06

Jubilant Pharmova Ltd

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Linezolid Form 1

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-14

Pay. Date : 2013-04-01

DMF Number : 26928

Submission : 2013-03-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Lacamas Laboratories Inc

USDMF

FNCE 2024

Not Confirmed

07

Lacamas Laboratories Inc

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

1lzd-linezolid, Step 1 (1lzd)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26552

Submission : 2014-05-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Raks Pharma Pvt Ltd

USDMF

FNCE 2024

Not Confirmed

08

Raks Pharma Pvt Ltd

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

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Digital Content

Linezolid Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26042

Submission : 2012-05-08

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Symed Labs Ltd

USDMF

FNCE 2024

Not Confirmed

09

Symed Labs Ltd

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Linezolid (form Iii)

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-15

Pay. Date : 2013-03-01

DMF Number : 20269

Submission : 2007-02-15

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Teva Pharmaceutical Industries Ltd

USDMF

FNCE 2024

Not Confirmed

10

Teva Pharmaceutical Industries Ltd

FNCE 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-23

Pay. Date : 2012-11-09

DMF Number : 19032

Submission : 2005-12-15

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

1
2
3

Linezolid Manufacturers | Traders | Suppliers

Linezolid Manufacturers, Traders, Suppliers 1

28

We have 24 companies offering Linezolid

Get in contact with the supplier of your choice:

Neuland Laboratories
Alembic Pharmaceuticals Limited
Amoli Organics
Apotex Pharmachem
Chongqing Huapont Pharmaceutical
Chromo Laboratories
Formosa Laboratories
GLAND PHARMA LIMITED
Glenmark Life Sciences
Grace
Jubilant Generics
LACAMAS LABORATORIES INC
Lee Pharma
Macleods Pharmaceuticals Limited
Optimus Pharma
Raks Pharma
Symed Labs
Teva API
UQUIFA
Zhejiang Hisun Pharmaceutical
Zhejiang Medicine Co Ltd
Zhejiang Neo-Dankong Pharm. Co.,Ltd.
Zhejiang Supor Pharmaceuticals Co., LTD
Zydus Lifesciences

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