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Generic Drug Facilities, Sites Self-Identified by Aspen Api with the US FDA. Original Data: FDA GDUFA Database

Aspen API

About, Contact Details

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2023, Corporate Presentation, GMP Certificate 2023, Green Answer to Peptide Synthesis, Your Personal API Partner, Product List 2021

VIDEO(s)

Green Continuous Liquid Phase Peptide Synthesis (GC-LPPS), Sustainable APIs Manufacturing 2022

DIGITAL CONTENT

1 Interviews #SpeakPharma, 3 Content #LearnMore About Supplier, 88 News

APIs // Active Pharmaceutical Ingredients

115 APIs, 60 USDMF, 27 CEP/COS, 14 JDMF, 15 KDMF, 62 NDC API, 90 Listed APIs

DEVELOPMENTS

10 Drug(s) in Development

10 Drug(s) in Development

DOSSIERs // Finished Dosage Forms

1860 Dossiers, 28 FDA Orange Book, 126 Europe, 62 Canada, 289 Australia, 1355 South Africa

KEY PRODUCTS

Azathioprine, Desogestrel, Dihydrotestosterone, Estriol, Etonogestrel, Fentanyl, Fentanyl Citrate, Fentanyl Hydrochloride, Ganirelix, Goserelin Acetate, Lanreotide Acetate, Oxytocin, Segesterone Acetate, Testosterone, Testosterone Acetate, Testosterone Cypionate, Testosterone Decanoate, Testosterone Dodecanoate, Testosterone Enanthate, Testosterone Isocaproate, Testosterone Phenylpropionate, Testosterone Propionate, Testosterone Undecanoate

SERVICES

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

All Services
Analytical
- 1 Analytical Method Development
API Manufacturing
API & Drug Product Development
- 8 API Development

KEY SERVICES

Contract Manufacturing for Steroid APIs, CDMO for Small Molecules

EXCIPIENTS

1 Regulatory Filings, 1 USDMF

INSPECTIONS & REGISTRATIONS

25 FDA, 30 EDQM, 6 GDUFA