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List of Drug Master Files (DMF) of Excipients submissions by Seqens to the U.S. FDA. Original Data : FDA Website

Seqens

About, Contact Details

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2023, Corporate Presentation, Products Under Development, Intermediates Product List 2022, GMP Certificate 2022, CDMO Brochure, Drug Delivery Solutions

VIDEO(s)

Seqens Essential Drug Substances, SEQENS Motion RD, Who is SEQENS?

DIGITAL CONTENT

2 Interview #SpeakPharma, 49 News

APIs // Active Pharmaceutical Ingredients

144 APIs, 103 USDMF, 46 CEP/COS, 27 JDMF, 23 KDMF, 100 NDC API, 84 Listed APIs

DEVELOPMENTS

No Content

DOSSIERs // Finished Dosage Forms

9 Dossiers, 9 Listed Dossiers

KEY PRODUCTS

Ciclopirox, Ciclopirox Olamine, Clascoterone, Granisetron, Granisetron Hydrochloride, Oxybutynin, Oxybutynin Hydrochloride, Remimazolam, Rotigotine, Ruxolitinib Phosphate, Sitagliptin Hydrochloride, Sitagliptin Phosphate, Sugammadex Sodium, Tapinarof, Troxerutin

SERVICES

All Services, Analytical, API Manufacturing, API & Drug Product Development

All Services
Analytical
- 1 Analytical Method Development
API Manufacturing
API & Drug Product Development
- 3 Preformulation & Material Science
- 12 API Development

KEY SERVICES

Custom Development & Manufacturing for APIs, Contract API Manufacturing Services, Contract Manufacturing of Potent Compounds, Spray Drying & Bioavailability Enhancement

EXCIPIENTS

3 Listed Products, 3 Regulatory Filings, 3 USDMF

EXCIPIENTS BY INGREDIENTS

Poly Epsilon Caprolactone, Poly DL Lactide co Glycolide , Vitamin E TPGS

EXCIPIENTS BY APPLICATIONS

Parenteral, Controlled & Modified Release, Co-Processed Excipients, Emulsifying Agents, Solubilizers, Surfactant & Foaming Agents

INSPECTIONS & REGISTRATIONS

29 FDA, 30 EDQM, 9 GDUFA