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Approved Drug Products containing MolPort-001-840-190 listed in the FDA Orange Book. Original Data : FDA Website

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Product

MolPort-001-840-190
FDA Orange Book

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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MolPort-001-840-190

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 8 USDMF, 4 CEP/COS, 1 EU WC, 1 KDMF, 7 NDC API, 7 Listed Suppliers, $ API Reference Price

13 API Suppliers
8 USDMF
4 CEP/COS
1 EU WC
1 KDMF
7 NDC API
7 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 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

53 FDF Dossiers, 11 FDA Orange Book, 31 Europe, 1 Canada, 2 South Africa, 8 Listed Dossiers

53 FDF Dossiers
11 FDA Orange Book
31 Europe
1 Canada
2 South Africa
8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 6MG/ML

SOLUTION;ORAL - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 6MG/ML

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 13 SPI Pharma, 2 Seqens, 7 DKSH, 2 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 BASF, 1 Clariant, 10 Corel Pharma Chem, 2 Finar, 5 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 14 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 3 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 14 Roquette, 7 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

46 Coating Systems & Additives, 28 Fillers, Diluents & Binders, 21 Controlled & Modified Release, 18 Film Formers & Plasticizers, 14 Taste Masking, 13 Topical, 13 Parenteral, 12 Thickeners and Stabilizers, 12 Chewable & Orodispersible Aids, 11 Direct Compression, 9 Empty Capsules, 8 Solubilizers, 6 Granulation, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Co-Processed Excipients, 4 Disintegrants & Superdisintegrants, 2 Emulsifying Agents, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

46 Coating Systems & Additives
28 Fillers, Diluents & Binders
21 Controlled & Modified Release
18 Film Formers & Plasticizers
14 Taste Masking
13 Topical
13 Parenteral
12 Thickeners and Stabilizers
12 Chewable & Orodispersible Aids
11 Direct Compression
9 Empty Capsules
8 Solubilizers
6 Granulation
5 Coloring Agents
4 Vegetarian Capsules
4 API Stability Enhancers
4 Co-Processed Excipients
4 Disintegrants & Superdisintegrants
2 Emulsifying Agents
2 Rheology Modifiers
1 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

10 NEWS #PharmaBuzz

10 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 25 Finished Drug Prices

2 US Medicaid Prescriptions
25 Finished Drug Prices

MARKET PLACE

9 APIs, 3 FDF Dossiers

9 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 1 Health Canada Patents

6 US Patents
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 3 Others

3 EDQM
3 USP
3 Others

$ API Ref.Price (USD/KG) : 323 Xls

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FILTER :

filter Applicant Reset all filters

11 All

01 2ALKEM LABS LTD

02 1ANNORA PHARMA

03 2AZURITY

04 1BAYER PHARMS

05 1BIONPHARMA

06 1HERITAGE

07 1SOFGEN PHARMS

08 1SUN PHARM INDS INC

09 1THEPHARMANETWORK LLC

filter Dosage Reset all filters

11 All

01 6CAPSULE;ORAL

02 5SOLUTION;ORAL

filter Regulatory Info Reset all filters

11 All

01 4DISCN

02 5RX

03 2Blank

filter Brand Name Reset all filters

11 All

01 8NIMODIPINE

02 1NIMOTOP

03 2NYMALIZE

filter RLD Reset all filters

11 All

01 6No

02 3Yes

03 2Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

ALKEM LABS LTD

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ALKEM LABS LTD

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RLD :

TE Code :

Brand Name : NIMODIPINE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 30MG/5ML

Approval Date :

Application Number : 213409

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Digital Content

Corporate PDF

02

ALKEM LABS LTD

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ALKEM LABS LTD

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RLD :

TE Code :

Brand Name : NIMODIPINE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 60MG/10ML

Approval Date :

Application Number : 213409

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Digital Content

Corporate PDF

03

HERITAGE

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HERITAGE

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RLD : No

TE Code : AB

Brand Name : NIMODIPINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG

Approval Date : 2007-05-02

Application Number : 77811

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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Corporate PDF

04

AZURITY

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AZURITY

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RLD : Yes

TE Code :

Brand Name : NYMALIZE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2013-05-10

Application Number : 203340

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

AZURITY

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AZURITY

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RLD : Yes

TE Code :

Brand Name : NYMALIZE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 6MG/ML

Approval Date : 2020-04-08

Application Number : 203340

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

BAYER PHARMS

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BAYER PHARMS

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RLD : Yes

TE Code :

Brand Name : NIMOTOP

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1988-12-28

Application Number : 18869

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

BIONPHARMA

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BIONPHARMA

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RLD : No

TE Code : AB

Brand Name : NIMODIPINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG

Approval Date : 2008-01-17

Application Number : 76740

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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Digital Content

Corporate PDF

08

SOFGEN PHARMS

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SOFGEN PHARMS

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RLD : No

TE Code :

Brand Name : NIMODIPINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG

Approval Date : 2015-07-24

Application Number : 201832

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

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Corporate PDF

09

SUN PHARM INDS INC

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SUN PHARM INDS INC

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RLD : No

TE Code :

Brand Name : NIMODIPINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG

Approval Date : 2007-04-17

Application Number : 77067

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

THEPHARMANETWORK LLC

U.S.A

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THEPHARMANETWORK LLC

U.S.A

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U.S.A

Digital Content

RLD : No

TE Code : AB

Brand Name : NIMODIPINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 30MG

Approval Date : 2014-04-07

Application Number : 90103

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Website

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