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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Minakem to the U.S. FDA. Original Data : FDA Website

Minakem

About, Contact Details

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2021, Corporate Presentation, GMP Certificate 2022, API Product List 2021, Building Blocks & GMP Excipients 2021, CDMO for Custom APIs & HPAPIs, Analytical Services, A Word With Minakem Teknoscienze, Minakem Interview, Challenging Chemistry in Pharmaceutical Manufacturing

VIDEO(s)

Corporate Video, High Containment Lab

DIGITAL CONTENT

3 Interview #SpeakPharma, 3 Supplier #LearnMore, 58 News

APIs // Active Pharmaceutical Ingredients

17 APIs, 6 USDMF, 9 CEP/COS, 3 JDMF, 9 KDMF, 9 NDC API, 14 Listed APIs

DEVELOPMENTS

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KEY PRODUCTS

1,1-Cyclobutane Dicarboxylic Acid, Budesonide, Cyclobutane Carboxaldehyde, Cyclopropyl Methyl Bromide, Cyclopropyl Methyl Chloride, Esomeprazole Magnesium, Esomeprazole Sodium, Fulvestrant, Ibrutinib, Methyl (1R,2S,5S)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxylate HCl, Propyl Gallate, Remifentanil, Vinblastine Sulfate, Vincristine Sulfate, Vinorelbine Tartrate

INTERMEDIATES

49 Listed Products

49 Listed Products

SERVICES

All Services, API Manufacturing, API & Drug Product Development

KEY SERVICES

High Potency API (HPAPI) Manufacturing, Continuous Flow Chemistry, Development of High Potency APIs (HPAPIs), Custom Synthesis & Development, Synthesis of Advanced Intermediates, Polymorph, Salt & Cocrystal Study

EXCIPIENTS

2 Listed Products

2 Listed Products

KEY EXCIPIENTS

Propyl Gallate GMP

Propyl Gallate GMP

EXCIPIENTS BY INGREDIENTS

Propyl Gallate, Sodium Stearyl Fumarate

EXCIPIENTS BY APPLICATIONS

Lubricants & Glidants, API Stability Enhancers

INSPECTIONS & REGISTRATIONS

13 FDA, 29 EDQM, 2 Others, 1 GDUFA

Minakem
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