FDA APPLICATION 75166 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Skyepharma

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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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Skyepharma

VIRTUAL BOOTH, Contact Details

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

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Corporate Presentation, French CDMO Drives Growth Through Leadership Change, Skyepharma Strengthens Oncology with New France Facility, Controlling Lag-time & Release Kinetics of Press-coated Tablets , Microfluidization - Skyepharma Collaboration with Lyon University, GMP Certificate 2024, Leading Pharmaceutical Development in a Sustainable Way, Skyepharma & MaaT Pharma launches a facility for Biotherapies, Services, Quality By Design & Expertise, Compaction Simulation Expertise

Corporate Presentation
French CDMO Drives Growth Through Leadership Change
Skyepharma Strengthens Oncology with New France Facility
Controlling Lag-time & Release Kinetics of Press-coated Tablets
Microfluidization - Skyepharma Collaboration with Lyon University
GMP Certificate 2024
Leading Pharmaceutical Development in a Sustainable Way
Skyepharma & MaaT Pharma launches a facility for Biotherapies
Services
Quality By Design & Expertise
Compaction Simulation Expertise

VIDEO(s)

HPAPI Area for Immuno-oncological Treatments, CDMO Expert in Complex Oral Solid Dosage Forms, Interview CPhI WW 2022, Services Presentation, Corporate Video - Center of Excellence, Agile CDMO Partner, Fully Integrated CDMO, Manufacturing Capabilities, Microfluidizer Technology, Pharmaceutical Development Services, Reliable CDMO Partner, Soctec® Technology, Pharmapack 2020- Interview with David Lescuyer, Packaging Services 2020, CPhI Worldwide 2018

HPAPI Area for Immuno-oncological Treatments
CDMO Expert in Complex Oral Solid Dosage Forms
Interview CPhI WW 2022
Services Presentation
Corporate Video - Center of Excellence
Agile CDMO Partner
Fully Integrated CDMO
Manufacturing Capabilities
Microfluidizer Technology
Pharmaceutical Development Services
Reliable CDMO Partner
Soctec® Technology
Pharmapack 2020- Interview with David Lescuyer
Packaging Services 2020
CPhI Worldwide 2018

DIGITAL CONTENT

2 Interview #SpeakPharma, 26 Corporate Content #SupplierSpotlight, 1 Data Compilation #PharmaFlow, 36 News #PharmaBuzz

2 Interview #SpeakPharma
26 Corporate Content #SupplierSpotlight
1 Data Compilation #PharmaFlow
36 News #PharmaBuzz

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 FDA Orange Book

1 FDF Dossiers
1 FDA Orange Book

SERVICES

Analytical, Drug Product Manufacturing, Sales, Marketing, Registration, Packaging, API & Drug Product Development

Analytical
- 1 Analytical Method Development
Drug Product Manufacturing
Sales, Marketing, Registration
- 1 Regulatory Affairs / Pharmacovigilance
Packaging
- 4 Contract Services
API & Drug Product Development
- 5 Formulation Development

KEY SERVICES

Modified Release Capsules, GEOMATRIX: Multi-layer Tablet Technology, SOCTEC - ER Gastro-retentive Technology, Immediate & Modified Release Tablets, Controlled Drug Delivery, GEOCLOCK - Tab-in-Tab Technology, Highly Potent Tablet Manufacturing, Complex OSD Manufacturing, ODT Manufacturing, Chewable Tablet Manufacturing, Bioproduction, Highly Potent Capsule Manufacturing

Modified Release Capsules
GEOMATRIX: Multi-layer Tablet Technology
SOCTEC - ER Gastro-retentive Technology
Immediate & Modified Release Tablets
Controlled Drug Delivery
GEOCLOCK - Tab-in-Tab Technology
Highly Potent Tablet Manufacturing
Complex OSD Manufacturing
ODT Manufacturing
Chewable Tablet Manufacturing
Bioproduction
Highly Potent Capsule Manufacturing

INSPECTIONS & REGISTRATIONS

6 FDA, 5 EDQM, 1 GDUFA

6 FDA
5 EDQM
1 GDUFA

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01 1SKYEPHARMA AG

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01 1TABLET, EXTENDED RELEASE;ORAL

filter Regulatory Info Reset all filters

1 All

01 1DISCN

filter Brand Name Reset all filters

1 All

01 1ISOSORBIDE MONONITRATE

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01 1No

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Brand Name : ISOSORBIDE MONONITRA...

Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

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Digital Content

RLD : No

TE Code :

ISOSORBIDE MONONITRATE

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ISOSORBIDE MONONITRATE

Dosage Strength : 60MG

Approval Date : 1999-10-07

Application Number : 75166

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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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.