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Pangea Biomed
FDA Orange Book

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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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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HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Aspen API. More than just an API™

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FAMAR CDMO- From early development to commercial manufacturing.

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Pangea Biomed

VISIT THE VIRTUAL BOOTH, Contact Details

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow

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DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

12 FDF Dossiers, 12 FDA Orange Book

12 FDF Dossiers
12 FDA Orange Book

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filter Active Ingredients Reset all filters

12 All

01 3BUSPIRONE HYDROCHLORIDE

02 2CELECOXIB

03 1DEXAMETHASONE

04 1ERGOTAMINE TARTRATE

05 2ETODOLAC

06 1OXAPROZIN

07 2TRIMETHOPRIM HYDROCHLORIDE

filter Dosage Reset all filters

12 All

01 5CAPSULE;ORAL

02 2SOLUTION;ORAL

03 4TABLET;ORAL

04 1TABLET;SUBLINGUAL

filter Dosage Strength Reset all filters

12 All

01 10.25MG

02 110MG

03 115MG

04 1200MG

05 12MG

06 2400MG

07 1500MG

08 1600MG

09 17.5MG

10 1EQ 25MG BASE/5ML

11 1EQ 50MG BASE/5ML

filter Regulatory Info Reset all filters

12 All

01 5DISCN

02 7RX

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01

Brand Name : BUSPIRONE HYDROCHLOR...

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Brand Name : BUSPIRONE HYDROCHLOR...

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RLD : No

TE Code :

BUSPIRONE HYDROCHLORIDE

Pangea Biomed

Dosage Form : CAPSULE; ORAL

Proprietary Name : BUSPIRONE HYDROCHLORIDE

Dosage Strength : 7.5MG

Approval Date : 2025-03-13

Application Number : 218628

RX/OTC/DISCN : RX

RLD : No

TE Code :

Product
Web Link

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02

Brand Name : BUSPIRONE HYDROCHLOR...

PREP

Not Confirmed

Brand Name : BUSPIRONE HYDROCHLOR...

PREP

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Digital Content

RLD : No

TE Code :

BUSPIRONE HYDROCHLORIDE

Pangea Biomed

Dosage Form : CAPSULE; ORAL

Proprietary Name : BUSPIRONE HYDROCHLORIDE

Dosage Strength : 10MG

Approval Date : 2025-03-13

Application Number : 218628

RX/OTC/DISCN : RX

RLD : No

TE Code :

Product
Web Link

Stock Recap
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03

Brand Name : BUSPIRONE HYDROCHLOR...

PREP

Not Confirmed

Brand Name : BUSPIRONE HYDROCHLOR...

PREP

Not Confirmed

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RLD : No

TE Code :

BUSPIRONE HYDROCHLORIDE

Pangea Biomed

Dosage Form : CAPSULE; ORAL

Proprietary Name : BUSPIRONE HYDROCHLORIDE

Dosage Strength : 15MG

Approval Date : 2025-03-13

Application Number : 218628

RX/OTC/DISCN : RX

RLD : No

TE Code :

Product
Web Link

Stock Recap
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04

Brand Name : CELECOXIB

PREP

Not Confirmed

Brand Name : CELECOXIB

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Digital Content

RLD : No

TE Code :

Pangea Biomed

Dosage Form : CAPSULE; ORAL

Proprietary Name : CELECOXIB

Dosage Strength : 200MG

Approval Date : 2020-12-09

Application Number : 212925

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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05

Brand Name : CELECOXIB

PREP

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Brand Name : CELECOXIB

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Digital Content

RLD : No

TE Code :

Pangea Biomed

Dosage Form : CAPSULE; ORAL

Proprietary Name : CELECOXIB

Dosage Strength : 400MG

Approval Date : 2020-12-09

Application Number : 212925

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

06

Brand Name : DEXAMETHASONE

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Brand Name : DEXAMETHASONE

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Digital Content

RLD : No

TE Code :

DEXAMETHASONE

Pangea Biomed

Dosage Form : TABLET; ORAL

Proprietary Name : DEXAMETHASONE

Dosage Strength : 0.25MG

Approval Date : 1983-04-28

Application Number : 88149

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

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07

Brand Name : ERGOMAR

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Brand Name : ERGOMAR

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Digital Content

RLD : No

TE Code :

ERGOTAMINE TARTRATE

Pangea Biomed

Dosage Form : TABLET; SUBLINGUAL

Proprietary Name : ERGOMAR

Dosage Strength : 2MG

Approval Date : 1983-02-24

Application Number : 87693

RX/OTC/DISCN : RX

RLD : No

TE Code :

Product
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08

Brand Name : ETODOLAC

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Brand Name : ETODOLAC

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Digital Content

RLD : No

TE Code : AB

Pangea Biomed

Dosage Form : TABLET; ORAL

Proprietary Name : ETODOLAC

Dosage Strength : 400MG

Approval Date : 1997-04-11

Application Number : 74903

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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09

Brand Name : ETODOLAC

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Brand Name : ETODOLAC

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Digital Content

RLD : No

TE Code : AB

Pangea Biomed

Dosage Form : TABLET; ORAL

Proprietary Name : ETODOLAC

Dosage Strength : 500MG

Approval Date : 1999-04-19

Application Number : 74903

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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10

Brand Name : OXAPROZIN

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Brand Name : OXAPROZIN

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RLD : No

TE Code : AB

Pangea Biomed

Dosage Form : TABLET; ORAL

Proprietary Name : OXAPROZIN

Dosage Strength : 600MG

Approval Date : 2001-01-31

Application Number : 75845

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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