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Manufacturers & Suppliers of Prestwick3_000358 Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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Product

Prestwick3_000358
Listed Dossiers

Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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xyz-pharma-m-2024-10-07

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Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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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-2024-10-07

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Prestwick3_000358

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 21 USDMF, 4 JDMF, 1 EU WC, 5 NDC API, 4 Listed Suppliers, $ API Reference Price

27 API Suppliers
21 USDMF
4 JDMF
1 EU WC
5 NDC API
4 Listed Suppliers
$ API Reference Price

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

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

157 FDF Dossiers, 93 FDA Orange Book, 6 Europe, 6 Canada, 2 South Africa, 50 Listed Dossiers

157 FDF Dossiers
93 FDA Orange Book
6 Europe
6 Canada
2 South Africa
50 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 6 SPI Pharma, 12 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 1 Clariant, 7 DFE Pharma, 2 Finar, 9 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 26 Kerry, 1 Kima Chemical, 3 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 23 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 12 Sigachi Industries, 1 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

67 Fillers, Diluents & Binders, 33 Thickeners and Stabilizers, 33 Direct Compression, 28 Disintegrants & Superdisintegrants, 19 Granulation, 18 Solubilizers, 17 Coating Systems & Additives, 16 Lubricants & Glidants, 16 Co-Processed Excipients, 14 Taste Masking, 13 Topical, 10 Parenteral, 10 Film Formers & Plasticizers, 9 Rheology Modifiers, 8 Controlled & Modified Release, 8 Empty Capsules, 7 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 4 Surfactant & Foaming Agents, 3 API Stability Enhancers, 3 Coloring Agents

67 Fillers, Diluents & Binders
33 Thickeners and Stabilizers
33 Direct Compression
28 Disintegrants & Superdisintegrants
19 Granulation
18 Solubilizers
17 Coating Systems & Additives
16 Lubricants & Glidants
16 Co-Processed Excipients
14 Taste Masking
13 Topical
10 Parenteral
10 Film Formers & Plasticizers
9 Rheology Modifiers
8 Controlled & Modified Release
8 Empty Capsules
7 Emulsifying Agents
6 Chewable & Orodispersible Aids
4 Surfactant & Foaming Agents
3 API Stability Enhancers
3 Coloring Agents

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 16 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
16 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 12 Finished Drug Prices

1 US Medicaid Prescriptions
12 Finished Drug Prices

MARKET PLACE

14 APIs, 4 FDF Dossiers

14 APIs
4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 USP, 10 Others

2 USP
10 Others

$ API Ref.Price (USD/KG) : 63 Xls

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50 All

01 7ACS DOBFAR SPA

02 2ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD

03 2Bernofarm Pharmaceutical Company

04 1Brix Biopharma

05 6DEVATS INDIA PRIVATE LTD

06 1Eloge

07 1Hainan Haiyao

08 2Hiral Labs

09 2IFA SA Laboratories

10 1JMW

11 1Kniss Laboratories

12 1Medipol Pharmaceutical

13 8Nectar Lifesciences Limited

14 1PVS Laboratories

15 1Scott-Edil Pharmacia

16 1Smith & Kenner Pharmaceuticals

17 3Umedica Laboratories Pvt Ltd

18 2Unosource Pharma

19 2XL Laboratories Private Limited

20 2Xepa-Soul Pattinson m SDN BHD

21 3Zeiss Pharma

filter Active Ingredients Reset all filters

50 All

01 50Cephalexin

filter Dosage Reset all filters

50 All

01 8CAPSULE

02 8Capsule

03 2Capsules

04 1Caspule

05 1DRY SYRUP

06 4Dispersible Tablet

07 1Dry Powder for Oral Suspension

08 1Dry Syrup

09 2Film Coated Tablet

10 3Hard Gelatin Capsule

11 1ORAL SUSPENSION

12 1Oral Powder for Reconstitution

13 2Oral Suspension

14 1Powder

15 1SUSPENSION

16 2Suspensions

17 3TABLET

18 5Tablet

19 3Tablets

filter Dosage Strength Reset all filters

50 All

01 10.125G

02 2100MG

03 1125MG

04 3125MG/5ML

05 6125mg

06 11GM

07 10250MG

08 4250mg

09 9500MG

10 7500mg

11 17.5%

12 1750MG

13 4Blank

filter Country Reset all filters

50 All

01 2Bolivia

02 2Cambodia

03 3China

04 31India

05 7Italy

06 2Malaysia

07 1Venezuela

08 1Vietnam

09 1Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

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Product Main Page

01

ACS DOBFAR SPA

AAPS 2024

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ACS DOBFAR SPA

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Registration Country : Italy

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Dosage Form : Capsules

Dosage Strength : 250MG

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Regulatory Info :

Registration Country : Italy

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01

ACS DOBFAR SPA

AAPS 2024

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ACS DOBFAR SPA

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02

ACS DOBFAR SPA

AAPS 2024

Not Confirmed

ACS DOBFAR SPA

AAPS 2024

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Dosage Form : Capsules

Dosage Strength : 500MG

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Registration Country : Italy

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02

ACS DOBFAR SPA

AAPS 2024

Not Confirmed

ACS DOBFAR SPA

AAPS 2024

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03

ACS DOBFAR SPA

AAPS 2024

Not Confirmed

ACS DOBFAR SPA

AAPS 2024

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Regulatory Info :

Registration Country : Italy

Brand Name :

Dosage Form : Suspensions

Dosage Strength : 125MG

Packaging :

Approval Date :

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Regulatory Info :

Registration Country : Italy

Portfolio PDF

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03

ACS DOBFAR SPA

AAPS 2024

Not Confirmed

ACS DOBFAR SPA

AAPS 2024

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Dosage : Suspensions

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Registration Country : Italy

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04

ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

AAPS 2024

Not Confirmed

ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

AAPS 2024

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Dosage Form : Oral Powder for Recons...

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Regulatory Info :

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04

ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

AAPS 2024

Not Confirmed

ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

AAPS 2024

Not Confirmed

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Dosage : Oral Powder for Recons...

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Registration Country : China

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05

ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

AAPS 2024

Not Confirmed

ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

AAPS 2024

Not Confirmed

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Regulatory Info :

Registration Country : China

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Dosage Form : Capsule

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Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

AAPS 2024

Not Confirmed

ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LT...

AAPS 2024

Not Confirmed

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06

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : India

Brand Name :

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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Digital Content

06

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Dosage : TABLET

Dosage Strength : 100MG

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07

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

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Regulatory Info : Generic

Registration Country : India

Brand Name :

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number : 62745

Regulatory Info : Generic

Registration Country : India

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Digital Content

07

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Packaging :

Regulatory Info : Generic

Dosage : TABLET

Dosage Strength : 250MG

Brand Name :

Approval Date :

Application Number : 62745

Registration Country : India

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Digital Content

08

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : India

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Dosage Form : TABLET

Dosage Strength : 750MG

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Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

Product Web Link

Digital Content

08

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

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Dosage : TABLET

Dosage Strength : 750MG

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Registration Country : India

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09

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

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Regulatory Info : Generic

Registration Country : India

Brand Name :

Dosage Form : CAPSULE

Dosage Strength : 100MG

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Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

Product Web Link

Digital Content

09

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Packaging :

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Dosage : CAPSULE

Dosage Strength : 100MG

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Approval Date :

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Registration Country : India

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Digital Content

10

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : India

Brand Name :

Dosage Form : CAPSULE

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

Product Web Link

Digital Content

10

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Packaging :

Regulatory Info : Generic

Dosage : CAPSULE

Dosage Strength : 250MG

Brand Name :

Approval Date :

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Registration Country : India

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Digital Content

11

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : India

Brand Name :

Dosage Form : CAPSULE

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

Product Web Link

Digital Content

11

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Packaging :

Regulatory Info : Generic

Dosage : CAPSULE

Dosage Strength : 500MG

Brand Name :

Approval Date :

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Registration Country : India

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Digital Content

12

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : India

Brand Name :

Dosage Form : DRY SYRUP

Dosage Strength : 125MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

Product Web Link

Digital Content

12

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Packaging :

Regulatory Info : Generic

Dosage : DRY SYRUP

Dosage Strength : 125MG/5ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Product Web Link

Digital Content

13

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : India

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

Product Web Link

Digital Content

13

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

Nectar Lifesciences Limited

AAPS 2024

Not Confirmed

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Packaging :

Regulatory Info : Generic

Dosage : Tablet

Dosage Strength : 500mg

Brand Name :

Approval Date :

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Registration Country : India

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Digital Content

14

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : India

Brand Name : UCEPH

Dosage Form : CAPSULE

Dosage Strength : 250MG

Packaging : Blister of 10s

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

14

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

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Packaging : Blister of 10s

Regulatory Info : Generic

Dosage : CAPSULE

Dosage Strength : 250MG

Brand Name : UCEPH

Approval Date :

Application Number :

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

15

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : India

Brand Name : UCEPH

Dosage Form : CAPSULE

Dosage Strength : 500MG

Packaging : Blister of 10s

Approval Date :

Application Number : 90836

Regulatory Info : Generic

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

15

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

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Digital Content

Packaging : Blister of 10s

Regulatory Info : Generic

Dosage : CAPSULE

Dosage Strength : 500MG

Brand Name : UCEPH

Approval Date :

Application Number : 90836

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

16

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : India

Brand Name : UCEPH

Dosage Form : SUSPENSION

Dosage Strength : 125MG/5ML

Packaging : 60ml bottle

Approval Date :

Application Number : 62778

Regulatory Info : Generic

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

16

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

Umedica Laboratories Pvt Ltd

AAPS 2024

Not Confirmed

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Digital Content

Packaging : 60ml bottle

Regulatory Info : Generic

Dosage : SUSPENSION

Dosage Strength : 125MG/5ML

Brand Name : UCEPH

Approval Date :

Application Number : 62778

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

17

Xepa-Soul Pattinson m SDN BHD

AAPS 2024

Not Confirmed

Xepa-Soul Pattinson m SDN BHD

AAPS 2024

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

Regulatory Info : Generic

Registration Country : Malaysia

Brand Name : Sofilex OS

Dosage Form : ORAL SUSPENSION

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Malaysia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

17

Xepa-Soul Pattinson m SDN BHD

AAPS 2024

Not Confirmed

Xepa-Soul Pattinson m SDN BHD

AAPS 2024

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

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Digital Content

Packaging :

Regulatory Info : Generic

Dosage : ORAL SUSPENSION

Dosage Strength :

Brand Name : Sofilex OS

Approval Date :

Application Number :

Registration Country : Malaysia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

18

Xepa-Soul Pattinson m SDN BHD

AAPS 2024

Not Confirmed

Xepa-Soul Pattinson m SDN BHD

AAPS 2024

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

Regulatory Info : Generic

Registration Country : Malaysia

Brand Name : Sofilex

Dosage Form : CAPSULE

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Malaysia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

18

Xepa-Soul Pattinson m SDN BHD

AAPS 2024

Not Confirmed

Xepa-Soul Pattinson m SDN BHD

AAPS 2024

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

Packaging :

Regulatory Info : Generic

Dosage : CAPSULE

Dosage Strength :

Brand Name : Sofilex

Approval Date :

Application Number :

Registration Country : Malaysia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

19

XL Laboratories Private Limited

AAPS 2024

Not Confirmed

XL Laboratories Private Limited

AAPS 2024

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

Regulatory Info : Generic

Registration Country : India

Brand Name : HALOCEF

Dosage Form : CAPSULE

Dosage Strength : 250MG

Packaging :

Approval Date :

Application Number : 90836

Regulatory Info : Generic

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

19

XL Laboratories Private Limited

AAPS 2024

Not Confirmed

XL Laboratories Private Limited

AAPS 2024

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

Packaging :

Regulatory Info : Generic

Dosage : CAPSULE

Dosage Strength : 250MG

Brand Name : HALOCEF

Approval Date :

Application Number : 90836

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

20

XL Laboratories Private Limited

AAPS 2024

Not Confirmed

XL Laboratories Private Limited

AAPS 2024

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

Regulatory Info : Generic

Registration Country : India

Brand Name : HALOCEF

Dosage Form : CAPSULE

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number : 90836

Regulatory Info : Generic

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

20

XL Laboratories Private Limited

AAPS 2024

Not Confirmed

XL Laboratories Private Limited

AAPS 2024

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

Packaging :

Regulatory Info : Generic

Dosage : CAPSULE

Dosage Strength : 500MG

Brand Name : HALOCEF

Approval Date :

Application Number : 90836

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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