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BY217
FDA Orange Book

PharmaCompass Sponsored Ads

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M2i Group Roflumilast

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xyz-pharma-m-2025-03-24

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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2025-03-17

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BY217

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 13 USDMF, 6 EU WC, 5 KDMF, 13 NDC API, 20 Listed Suppliers, $ API Reference Price

38 API Suppliers
13 USDMF
6 EU WC
5 KDMF
13 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

86 Drugs in Development

86 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

50 FDF Dossiers, 25 FDA Orange Book, 14 Europe, 3 Canada, 1 South Africa, 7 Listed Dossiers

50 FDF Dossiers
25 FDA Orange Book
14 Europe
3 Canada
1 South Africa
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MCG, TABLET;ORAL - 500MCG

TABLET;ORAL - 250MCG
TABLET;ORAL - 500MCG

RELATED EXCIPIENT COMPANIES

3 SPI Pharma, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 2 DFE Pharma, 1 Gangwal Chemicals, 2 Ingredion Pharma Solutions, 15 Kerry, 8 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 6 Roquette, 1 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Sigachi Industries, 1 Vasa Pharmachem

3 SPI Pharma
4 Faran Shimi Pharmaceutical
1 Boai NKY Pharmaceuticals Ltd
2 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
9 BASF
2 DFE Pharma
1 Gangwal Chemicals
2 Ingredion Pharma Solutions
15 Kerry
8 Microlex e.U
1 Novo Excipients
1 Pharmatrans-Sanaq
4 Pluviaendo
1 Prachin Chemical
6 Roquette
1 Seppic
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 Sigachi Industries
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

41 Fillers, Diluents & Binders, 11 Direct Compression, 10 Granulation, 8 Lubricants & Glidants, 6 Solubilizers, 5 Co-Processed Excipients, 4 Disintegrants & Superdisintegrants, 4 Controlled & Modified Release, 3 Taste Masking, 3 Parenteral, 3 Chewable & Orodispersible Aids, 3 Thickeners and Stabilizers, 2 Coating Systems & Additives, 1 Film Formers & Plasticizers, 1 Emulsifying Agents

41 Fillers, Diluents & Binders
11 Direct Compression
10 Granulation
8 Lubricants & Glidants
6 Solubilizers
5 Co-Processed Excipients
4 Disintegrants & Superdisintegrants
4 Controlled & Modified Release
3 Taste Masking
3 Parenteral
3 Chewable & Orodispersible Aids
3 Thickeners and Stabilizers
2 Coating Systems & Additives
1 Film Formers & Plasticizers
1 Emulsifying Agents

DIGITAL CONTENT

98 News #PharmaBuzz

98 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 13 Regulatory FDF Prices, 10 Annual Reports

2 US Medicaid Prescriptions
13 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

14 APIs, 1 FDF Dossiers

14 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

42 US Patents, 4 US Exclusivities, 4 Health Canada Patents

42 US Patents
4 US Exclusivities
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 Others

5 Others

$ API Ref.Price (USD/KG) : 158,313 Xls

Filters

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25 All

01 2STRIDES PHARMA

02 2ALKEM LABS LTD

03 3ARCUTIS

04 2ASTRAZENECA

05 2AUROBINDO PHARMA LTD

06 2HETERO LABS LTD III

07 2MICRO LABS

08 2MSN

09 1NORVIUM BIOSCIENCE

10 1PRINSTON INC

11 2SENORES PHARMS

12 2TORRENT

13 2ZYDUS PHARMS

filter Dosage Reset all filters

25 All

01 2CREAM;TOPICAL

02 1FOAM;TOPICAL

03 22TABLET;ORAL

filter Regulatory Info Reset all filters

25 All

01 3DISCN

02 22RX

filter Brand Name Reset all filters

25 All

01 2DALIRESP

02 20ROFLUMILAST

03 3ZORYVE

filter RLD Reset all filters

25 All

01 20No

02 5Yes

List of Suppliers

Product Main Page

01

STRIDES PHARMA

CPhI WW Frankfurt

Booth # 9.1F6 & 9.1G41

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

Contact Supplier

Digital Content

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2020-03-30

Application Number : 208247

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

Product Web Link

Digital Content

02

STRIDES PHARMA

CPhI WW Frankfurt

Booth # 9.1F6 & 9.1G41

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

Contact Supplier

Digital Content

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2023-06-20

Application Number : 208247

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

Product Web Link

Digital Content

03

ASTRAZENECA

Peptide Therapy Summit

Not Confirmed

ASTRAZENECA

Peptide Therapy Summit

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

RLD : Yes

TE Code : AB

ROFLUMILAST

Brand Name : DALIRESP

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2011-02-28

Application Number : 22522

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

ASTRAZENECA

Peptide Therapy Summit

Not Confirmed

ASTRAZENECA

Peptide Therapy Summit

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

RLD : Yes

TE Code : AB

ROFLUMILAST

Brand Name : DALIRESP

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2018-01-23

Application Number : 22522

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

HETERO LABS LTD III

Peptide Therapy Summit

Not Confirmed

HETERO LABS LTD III

Peptide Therapy Summit

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

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2018-11-23

Application Number : 208213

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

HETERO LABS LTD III

Peptide Therapy Summit

Not Confirmed

HETERO LABS LTD III

Peptide Therapy Summit

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

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2023-04-18

Application Number : 208213

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

MICRO LABS

Peptide Therapy Summit

Not Confirmed

MICRO LABS

Peptide Therapy Summit

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

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2019-03-22

Application Number : 208180

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

MICRO LABS

Peptide Therapy Summit

Not Confirmed

MICRO LABS

Peptide Therapy Summit

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

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2023-04-18

Application Number : 208180

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

SENORES PHARMS

Peptide Therapy Summit

Not Confirmed

SENORES PHARMS

Peptide Therapy Summit

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

RLD : No

TE Code :

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2018-10-03

Application Number : 208236

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

Digital Content

Corporate PDF

10

SENORES PHARMS

Peptide Therapy Summit

Not Confirmed

SENORES PHARMS

Peptide Therapy Summit

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

RLD : No

TE Code :

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2023-10-19

Application Number : 208236

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

Digital Content

Corporate PDF

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