FDA APPLICATION 203022 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Apotex Inc

Trusted Global CDMO Partner Delivering End-to-End Pharma Manufacturing & Development Solutions.

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Evonik Health Care is the innovation hub for leading life science companies

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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

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Axplora is your partner of choice for complex APIs.

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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pharmacompass-2-2026-02-09

Apotex Inc

VIRTUAL BOOTH, Contact Details

VIRTUAL BOOTH
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 307 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
307 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

223 All APIs, 185 USDMF, 19 CEP/COS, 1 JDMF, 6 EU WC, 5 KDMF, 30 NDC API, 36 Listed APIs

223 All APIs
185 USDMF
19 CEP/COS
1 JDMF
6 EU WC
5 KDMF
30 NDC API
36 Listed APIs

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2565 FDF Dossiers, 708 FDA Orange Book, 190 Europe, 739 Canada, 928 Australia

2565 FDF Dossiers
708 FDA Orange Book
190 Europe
739 Canada
928 Australia

EXCIPIENTS

1 All Excipients, 1 USDMF

1 All Excipients
1 USDMF

REF. STANDARDS & IMPURITIES

1 Others

1 Others

INSPECTIONS & REGISTRATIONS

70 FDA, 6 EDQM, 2 WHO-GMP, 9 GDUFA, 1 Third-Party Audit

70 FDA
6 EDQM
2 WHO-GMP
9 GDUFA
1 Third-Party Audit

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Dosage Form : CAPSULE; ORAL

Proprietary Name : PREGABALIN

Dosage Strength : 150MG

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Application Number : 203022

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Dosage Form : CAPSULE; ORAL

Proprietary Name : PREGABALIN

Dosage Strength : 50MG

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Application Number : 203022

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Dosage Form : CAPSULE; ORAL

Proprietary Name : PREGABALIN

Dosage Strength : 75MG

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Application Number : 203022

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Dosage Form : CAPSULE; ORAL

Proprietary Name : PREGABALIN

Dosage Strength : 300MG

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Application Number : 203022

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Dosage Form : CAPSULE; ORAL

Proprietary Name : PREGABALIN

Dosage Strength : 200MG

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Application Number : 203022

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Dosage Form : CAPSULE; ORAL

Proprietary Name : PREGABALIN

Dosage Strength : 100MG

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Application Number : 203022

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TE Code :

Product
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Brand Name : PREGABALIN

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Dosage Form : CAPSULE; ORAL

Proprietary Name : PREGABALIN

Dosage Strength : 25MG

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Application Number : 203022

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RLD :

TE Code :

Product
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08

Brand Name : PREGABALIN

BePharma

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TE Code :

Dosage Form : CAPSULE; ORAL

Proprietary Name : PREGABALIN

Dosage Strength : 225MG

Approval Date :

Application Number : 203022

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.