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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-2025-04-21

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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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USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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xyz-pharma-m-2025-04-14

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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, 12 USDMF, 6 EU WC, 6 KDMF, 13 NDC API, 21 Listed Suppliers, $ API Reference Price

38 API Suppliers
12 USDMF
6 EU WC
6 KDMF
13 NDC API
21 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, 1 Ashland, 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 Silverline Chemicals, 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
1 Ashland
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 Silverline Chemicals
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

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

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

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

15 APIs, 1 FDF Dossiers

15 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) : 158,333 Xls

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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

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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

euroPLX 88 Lisbon

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

Contact Supplier

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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

euroPLX 88 Lisbon

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

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Not Confirmed

ASTRAZENECA

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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

Cophex

Not Confirmed

ASTRAZENECA

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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

Cophex

Not Confirmed

HETERO LABS LTD III

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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

Cophex

Not Confirmed

HETERO LABS LTD III

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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

Cophex

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MICRO LABS

Cophex

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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

Cophex

Not Confirmed

MICRO LABS

Cophex

Not Confirmed

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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

Cophex

Not Confirmed

SENORES PHARMS

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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

Cophex

Not Confirmed

SENORES PHARMS

Cophex

Not Confirmed

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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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