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Approved Drug Products containing Semaglutide listed in the FDA Orange Book. Original Data : FDA Website

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Product

Semaglutide
FDA Orange Book

PharmaCompass Sponsored Ads

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CCSB Semaglutide

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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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PharmaCompass Sponsored Ads

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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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Semaglutide

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 30 USDMF, 1 EU WC, 3 KDMF, 56 NDC API, 34 Listed Suppliers, $ API Reference Price

60 API Suppliers
30 USDMF
1 EU WC
3 KDMF
56 NDC API
34 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

54 Drugs in Development

54 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

62 FDF Dossiers, 14 FDA Orange Book, 12 Europe, 11 Canada, 4 Australia, 2 South Africa, 19 Listed Dossiers

62 FDF Dossiers
14 FDA Orange Book
12 Europe
11 Canada
4 Australia
2 South Africa
19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.68MG/ML), SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1.34MG/ML), SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.34MG/ML), SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.68MG/ML)

SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.68MG/ML)
SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1.34MG/ML)
SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.34MG/ML)
SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.68MG/ML)

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 1 BASF, 1 Finar, 1 Valens Pharmachem

1 Nanjing Well Pharmaceutical
1 BASF
1 Finar
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

3 Topical, 2 Film Formers & Plasticizers, 2 Solubilizers, 1 Thickeners and Stabilizers, 1 Parenteral, 1 Emulsifying Agents

3 Topical
2 Film Formers & Plasticizers
2 Solubilizers
1 Thickeners and Stabilizers
1 Parenteral
1 Emulsifying Agents

DIGITAL CONTENT

9 DATA COMPILATION #PharmaFlow, 9 STOCK RECAP #PipelineProspector, 419 NEWS #PharmaBuzz

9 DATA COMPILATION #PharmaFlow
9 STOCK RECAP #PipelineProspector
419 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 12 Finished Drug Prices, 13 Annual Reports

1 US Medicaid Prescriptions
12 Finished Drug Prices
13 Annual Reports

MARKET PLACE

44 APIs, 5 FDF Dossiers

44 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

147 US Patents, 17 US Exclusivities

147 US Patents
17 US Exclusivities

$ API Ref.Price (USD/KG) : 651,163 Xls

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FILTER :

filter Applicant Reset all filters

14 All

01 12NOVO

02 2NOVO NORDISK INC

filter Dosage Reset all filters

14 All

01 9SOLUTION;SUBCUTANEOUS

02 5TABLET;ORAL

filter Regulatory Info Reset all filters

14 All

01 12RX

02 2Blank

filter Brand Name Reset all filters

14 All

01 4OZEMPIC

02 5RYBELSUS

03 5WEGOVY

filter RLD Reset all filters

14 All

01 12Yes

02 2Blank

Bachem Semaglutide

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

NOVO

Discovery on Target

Not Confirmed

NOVO

Discovery on Target

Not Confirmed

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RLD : Yes

TE Code :

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 2MG/1.5ML (1.34MG/ML)

Approval Date : 2017-12-05

Application Number : 209637

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

NOVO

Discovery on Target

Not Confirmed

NOVO

Discovery on Target

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 4MG/3ML (1.34MG/ML)

Approval Date : 2019-04-09

Application Number : 209637

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

NOVO

Discovery on Target

Not Confirmed

NOVO

Discovery on Target

Not Confirmed

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RLD : Yes

TE Code :

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 8MG/3ML (2.68MG/ML)

Approval Date : 2022-03-28

Application Number : 209637

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

NOVO

Discovery on Target

Not Confirmed

NOVO

Discovery on Target

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 2MG/3ML (0.68MG/ML)

Approval Date : 2022-10-06

Application Number : 209637

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

NOVO

Discovery on Target

Not Confirmed

NOVO

Discovery on Target

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET;ORAL

Dosage Strength : 3MG

Approval Date : 2019-09-20

Application Number : 213051

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

NOVO

Discovery on Target

Not Confirmed

NOVO

Discovery on Target

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET;ORAL

Dosage Strength : 7MG

Approval Date : 2019-09-20

Application Number : 213051

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

NOVO

Discovery on Target

Not Confirmed

NOVO

Discovery on Target

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET;ORAL

Dosage Strength : 14MG

Approval Date : 2019-09-20

Application Number : 213051

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

NOVO NORDISK INC

Discovery on Target

Not Confirmed

NOVO NORDISK INC

Discovery on Target

Not Confirmed

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Digital Content

RLD :

TE Code :

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET;ORAL

Dosage Strength : 3MG

Approval Date :

Application Number : 213182

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

NOVO NORDISK INC

Discovery on Target

Not Confirmed

NOVO NORDISK INC

Discovery on Target

Not Confirmed

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Digital Content

RLD :

TE Code :

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET;ORAL

Dosage Strength : 7MG

Approval Date :

Application Number : 213182

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

NOVO

Discovery on Target

Not Confirmed

NOVO

Discovery on Target

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 0.25MG/0.5ML (0.25MG/0.5ML)

Approval Date : 2021-06-04

Application Number : 215256

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Product Web Link

Digital Content

Corporate PDF

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