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

Client Email

Product

Indo-Lemmon
USDMF

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Indo-Lemmon

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 13 USDMF, 6 CEP/COS, 12 JDMF, 1 EU WC, 6 NDC API, 16 Listed Suppliers, $ API Reference Price

38 API Suppliers
13 USDMF
6 CEP/COS
12 JDMF
1 EU WC
6 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

176 FDF Dossiers, 83 FDA Orange Book, 28 Europe, 7 Canada, 8 Australia, 21 South Africa, 29 Listed Dossiers

176 FDF Dossiers
83 FDA Orange Book
28 Europe
7 Canada
8 Australia
21 South Africa
29 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION;ORAL - 25MG/5ML, CAPSULE;ORAL - 20MG, CAPSULE;ORAL - 40MG

SUSPENSION;ORAL - 25MG/5ML
CAPSULE;ORAL - 20MG
CAPSULE;ORAL - 40MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Evonik, 3 Rochem International Inc, 18 SPI Pharma, 9 DKSH, 3 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 22 BASF, 1 Clariant, 17 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 11 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 32 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

94 Fillers, Diluents & Binders, 73 Coating Systems & Additives, 43 Direct Compression, 43 Controlled & Modified Release, 34 Disintegrants & Superdisintegrants, 33 Thickeners and Stabilizers, 31 Solubilizers, 28 Granulation, 27 Lubricants & Glidants, 27 Film Formers & Plasticizers, 26 Parenteral, 26 Taste Masking, 18 Chewable & Orodispersible Aids, 18 Co-Processed Excipients, 12 Topical, 10 Emulsifying Agents, 9 Empty Capsules, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

94 Fillers, Diluents & Binders
73 Coating Systems & Additives
43 Direct Compression
43 Controlled & Modified Release
34 Disintegrants & Superdisintegrants
33 Thickeners and Stabilizers
31 Solubilizers
28 Granulation
27 Lubricants & Glidants
27 Film Formers & Plasticizers
26 Parenteral
26 Taste Masking
18 Chewable & Orodispersible Aids
18 Co-Processed Excipients
12 Topical
10 Emulsifying Agents
9 Empty Capsules
7 Rheology Modifiers
6 API Stability Enhancers
5 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 21 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
21 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 31 Finished Drug Prices

1 US Medicaid Prescriptions
31 Finished Drug Prices

MARKET PLACE

43 APIs, 6 FDF Dossiers

43 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 2 US Exclusivities

6 US Patents
2 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 4 JP, 6 Others

2 EDQM
2 USP
4 JP
6 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

$ API Ref.Price (USD/KG) : 59 Xls

Filters

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13 All

01 1Aurore Life Sciences

02 1CSPC Pharmaceutical Group

03 1Chemi SpA

04 1EURAND INC

05 1Esteve Quimica

06 1F.I.S. Fabbrica Italiana Sintetici

07 1Genus Lifesciences

08 1Hetero Drugs

09 1Industriale Chimica

10 1Macleods Pharmaceuticals Limited

11 1SIGMA TAU

12 2Blank

filter Subject Reset all filters

13 All

01 9INDOMETHACIN

02 1INDOMETHACIN FOR HUMAN USE

03 1INDOMETHACIN USP

04 1INDOMETHACINE USP XX

05 1TIVORBEX (INDOMETHACIN) CAPSULES

filter Country Reset all filters

13 All

01 1China

02 3India

03 3Italy

04 1Spain

05 3U.S.A

06 2Blank

filter Status Reset all filters

13 All

01 6Active

02 7Inactive

filter GDUFA DMF Review Reset all filters

13 All

01 4Complete

02 9Blank

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Aurore Life Sciences Private Ltd

USDMF

Formnext Forum

Not Confirmed

01

Aurore Life Sciences Private Ltd

Formnext Forum

Not Confirmed

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Digital Content

Indomethacin Usp

GDUFA

DMF Review : Complete

Rev. Date : 2022-05-11

Pay. Date : 2022-03-31

DMF Number : 36761

Submission : 2022-02-03

Status : Active

Type : II

Product Web Link

Digital Content

02

Chemi Spa

USDMF

Formnext Forum

Not Confirmed

02

Chemi Spa

Formnext Forum

Not Confirmed

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Digital Content

Indomethacine Usp Xx

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4394

Submission : 1982-01-18

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Cspc Ouyi Pharmaceutical Co Ltd

USDMF

Formnext Forum

Not Confirmed

03

Cspc Ouyi Pharmaceutical Co Ltd

Formnext Forum

Not Confirmed

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Digital Content

Indomethacin

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21984

Submission : 2008-09-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Esteve Quimica Sa

USDMF

Formnext Forum

Not Confirmed

04

Esteve Quimica Sa

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Not Confirmed

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Digital Content

Indomethacin For Human Use

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4220

Submission : 1981-03-18

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Fis Fabbrica Italiana Sintetici Spa

USDMF

Formnext Forum

Not Confirmed

05

Fis Fabbrica Italiana Sintetici Spa

Formnext Forum

Not Confirmed

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Digital Content

Indomethacin

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-26

Pay. Date : 2013-02-07

DMF Number : 3136

Submission : 1978-01-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Genus Lifesciences Inc

USDMF

Formnext Forum

Not Confirmed

06

Genus Lifesciences Inc

Formnext Forum

Not Confirmed

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Digital Content

Tivorbex (indomethacin) Capsules

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26340

Submission : 2013-04-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Hetero Drugs Ltd

USDMF

Formnext Forum

Not Confirmed

07

Hetero Drugs Ltd

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Not Confirmed

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Digital Content

Indomethacin

GDUFA

DMF Review : Complete

Rev. Date : 2021-11-22

Pay. Date : 2021-10-21

DMF Number : 36364

Submission : 2021-10-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Industrie Chimiche Farmaceutiche Ita...

USDMF

Formnext Forum

Not Confirmed

08

Industrie Chimiche Farmaceutiche Ita...

Formnext Forum

Not Confirmed

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Digital Content

Indomethacin

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2633

Submission : 1976-03-01

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Macleods Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

09

Macleods Pharmaceuticals Ltd

Formnext Forum

Not Confirmed

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Digital Content

Indomethacin

GDUFA

DMF Review : Complete

Rev. Date : 2021-08-27

Pay. Date : 2021-07-08

DMF Number : 21740

Submission : 2008-06-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

10

Sigma F And D Div Ltd

USDMF

Formnext Forum

Not Confirmed

10

Sigma F And D Div Ltd

Formnext Forum

Not Confirmed

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Digital Content

Indomethacin

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5258

Submission : 1983-07-20

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Indo-Lemmon Manufacturers | Traders | Suppliers

Indo-Lemmon Manufacturers, Traders, Suppliers 1

42

We have 11 companies offering Indo-Lemmon

Get in contact with the supplier of your choice:

Aurore Life Sciences
Chemi SpA
CSPC Pharmaceutical Group
Esteve Quimica
EURAND INC
F.I.S. Fabbrica Italiana Sintetici
Genus Lifesciences
Hetero Drugs
Industriale Chimica
Macleods Pharmaceuticals Limited
SIGMA TAU

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