Athena Pharmaceutiques Oral Dispersible Tablets

Athena Pharmaceutiques Oral Dispersible Tablets

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List of CMO and CDMO services of Catalent Pharma Solutions

CATALENT PHARMA SOLUTIONS

About, Contact Details

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Corporate Presentation, GMP Certificate 2021

VIDEO(s)

Corporate Video, Flexible Filling Line, Metered Dose Inhaler (MDI) Services, Nasal Spray Manufacturing, Secondary Packaging Capability, Softgel Technology, Syringe Filling Line, Vial Filling Line, Zydis® ODT

DIGITAL CONTENT

404 News

404 News

APIs // Active Pharmaceutical Ingredients

82 APIs, 81 USDMF, 1 JDMF, 44 NDC API

DEVELOPMENTS

51 Drug(s) in Development

51 Drug(s) in Development

DOSSIERs // Finished Dosage Formulations

3 Dossiers, 3 FDA Orange Book

SERVICES

All Services, Analytical, API Manufacturing, Drug Product Manufacturing, Sales, Marketing, Registration, Clinical Trials, API & Drug Product Development, Packaging

All Services
Analytical
- 1 Analytical Testing Services
- 1 Analytical Method Development
API Manufacturing
- 1 Micronization
Drug Product Manufacturing
Sales, Marketing, Registration
- 1 Regulatory Affairs / Pharmacovigilance
Clinical Trials
- 2 Packaging & Logistics
API & Drug Product Development
- 2 Preformulation & Material Science
- 8 Formulation Development
Packaging
- 3 Clinical Services
- 4 Contract Services

EXCIPIENTS

8 Regulatory Filings, 8 USDMF

INSPECTIONS & REGISTRATIONS

130 FDA, 69 EDQM, 17 GDUFA

List of Services

List of Services

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Catalent Pharma Solutions

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FORMULATION DEVELOPMENT OF INHALED PRODUCTS

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Catalent has more than 30 years of experience in supporting the development of inhaled products, and full commercial-scale manufacturing capabilities for DPIs, MDIs and unit-dose or bi-dose nasal sprays.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Inhalation / Nasal

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CONTRACT MANUFACTURING FOR NASAL DOSAGE FORMS

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Catalent provides complete clinical and commercial manufacturing for nasal dosage forms with a track record of regulatory success around the globe.

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Pharma Service: Drug Product Manufacturing

Category: Nasal

Sub Category: Overview

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NASAL SPRAY CLINICAL SUPPLY

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Catalent offers complete clinical trial materials preparation in support of Phase I – IV studies for nasal dosage forms and provides seamless technology transfer to its commercial manufacturing facilities.

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Pharma Service: Drug Product Manufacturing

Category: Nasal

Sub Category: Clinical Supply

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CONTRACT MANUFACTURING FOR NASAL SPRAY

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Catalent offers the development of inhaled products and the full commercial-scale contract manufacturing of DPIs, MDIs and unit-dose or bi-dose nasal sprays. It also provides complete, end-to-end solutions for today’s handheld inhalation dosage forms.

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Pharma Service: Drug Product Manufacturing

Category: Spray

Sub Category: Nasal

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INJECTABLE DRUG PRODUCT MANUFACTURING

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Catalent offers injectable drug product manufacturing, filling & packaging services. They handle small molecules, biologics, & vaccines within their automated filling lines offering the highest degree of aseptic processing.

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Pharma Service: Drug Product Manufacturing

Category: Injectable / Parenteral

Sub Category: Overview

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ZYDIS® FAST DISSOLVING TABLET TECHNOLOGY

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Catalent's Zydis® ODT fast-dissolve formulation is a unique, freeze-dried oral solid dosage form that disperses instantly in the mouth. With more than 20 products launched in 60 countries, it continues to be the world’s best-in-class ODT technology.

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Pharma Service: Drug Product Manufacturing

Category: Technologies

Sub Category: Orally Disintegrating Tablets (ODTs)

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LIPID BASED DRUG DELIVERY

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As the innovator of softgel technologies, Catalent RP Scherer softgel brings more than 80 years of drug development solutions expertise and manufacturing services experience to the full spectrum of lipid-based drug delivery.

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Pharma Service: Drug Product Manufacturing

Category: Technologies

Sub Category: Drug Delivery

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BIOAVAILABILITY ENHANCEMENT TECHNOLOGIES

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Catalent solves complex bioavailability challenges with a variety of formulation technologies. They have development & formulation expertise to solve bioavailability challenges through spray drying, lipid based formulations, hot melt extrusion, etc.

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Pharma Service: Drug Product Manufacturing

Category: Technologies

Sub Category: Bioavailability Enhancement

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ORAL DOSE TECHNOLOGIES

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With a wide range of oral dose technologies, Catalent provides fast, flexible and seamless transition from early-phase development to late phase development and manufacturing services up to commercialization, to meet your needs in fast track programs.

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Pharma Service: Drug Product Manufacturing

Category: Technologies

Sub Category: Oral Dose Technologies

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NASAL SOLUTION & SUSPENSION

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Catalent has decades of experience with all pulmonary and nasal dosage forms including MDIs, DPIs, nasal sprays, solutions and suspensions for inhalation.

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Pharma Service: Drug Product Manufacturing

Category: Solution

Sub Category: Nasal

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CLINICAL PACKAGING & LABELING

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Catalent offers labeling assistance for clinical trial material (CTM) and regulatory label review for US, EU, Israel, Eastern Europe and Russia, Canada, Australia and New Zealand, Asia Pacific, and Latin America.

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Pharma Service: Packaging

Category: Clinical Services

Sub Category: Label

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FORMULATION DEVELOPMENT FOR CLINICAL SUPPLY

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Catalent offers comprehensive clinical supply services. It offers the broadest spectrum of global development and clinical supply services for studies of all sizes and complexities from Phase I to III and beyond.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Clinical Supply

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HOT MELT EXTRUSION

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OptiMelt® is Catalent’s unique ability to formulate, develop and commercialize hot melt extrusion processes and integrate these into differentiated final dosage forms. Hot melt extrusion enhances solubility and bioavailability for poorly soluble drugs.

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Pharma Service: Drug Product Manufacturing

Category: Technologies

Sub Category: Granulation & Extrusion

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SPRAY DRYING SOLUTIONS

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Catalent offers spray drying solutions from early-phase development through to clinical supply, and scale-up to commercial volumes of finished dose forms. Spray drying has been proven to improve the bioavailability of poorly soluble compounds.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Spray Drying

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DRY POWDER INHALERS (DPIS)

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Catalent offers the best-in-class commercial-scale powder and capsule manufacture for Dry Powder Inhalers (DPIs) out of its Boston, MA facility. With a proven track record, the Boston-area team are experts in spray dry inhalation technology.

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Pharma Service: Drug Product Manufacturing

Category: Powder

Sub Category: Inhalation

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CLINICAL PACKAGING - HDPE BOTTLES

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Catalent's clinical trial manufacturing & packaging services offer formulation development and primary packaging including HDPE bottles and blisters.

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Pharma Service: Packaging

Category: Clinical Services

Sub Category: Bottle

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BIOLOGICAL DRUG PRODUCTS

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Catalent provides injectable drug product manufacturing, filling & packaging. They handle biologics, vaccines & small molecules within their automated filling lines offering the highest degree of aseptic processing with your choice of isolator technology.

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Pharma Service: Drug Product Manufacturing

Category: Biologic Drugs

Sub Category: Overview

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INJECTABLE FILLING & PACKAGING IN CARTRIDGES

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Catalent's drug product manufacturing can formulate, fill and package your product into a cartridge, vial or syringe making it ready to use for a patient or health care professional.

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Pharma Service: Packaging

Category: Contract Services

Sub Category: Cartridge

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VIAL FILLING & PACKAGING

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Catalent's drug product manufacturing can formulate, fill and package your product into a final vial, syringe or cartridge presentation, making it ready to use for a patient or health care professional.

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Pharma Service: Packaging

Category: Contract Services

Sub Category: Vial

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REGULATORY SUPPORT SERVICES

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Catalent offers customized regulatory affairs services for global markets and supports the full product lifecycle for products contract manufactured at Catalent. The regulatory submission CMC writing includes IND, CTA, NDA, MAA, NDS, ANDA, BLA, DMF, etc.

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: United States

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SCALE-UP CAPABILITIES

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Catalent provides a full-range of formulated study supplies & services including preclinical, prototype formulation screening studies, clinical trial materials support, scale-up, technology transfer, commercial manufacturing technical support, etc.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Scale-Up Capabilities

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SCALE UP & TECHNOLOGY TRANSFER

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Catalent offers various services including preclinical (GLP toxicology), prototype formulation screening studies, Phase I – Phase III clinical trial materials support, scale-up, technology transfer, commercial manufacturing technical support, etc.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Tech Transfer

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CLINICAL MANUFACTURING FOR ORAL LIQUIDS

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Catalent's clinical trial manufacturing services & formulation development expertise are supported by its analytical & materials characterization capabilities. Its clinical trial manufacturing service offerings include oral liquids and suspensions.

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Pharma Service: Drug Product Manufacturing

Category: Liquid

Sub Category: Clinical Supply

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PHARMACEUTICAL CONTRACT MICRONIZATION

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Catalent Micron Technologies is a leading international provider of particle size reduction services. They deliver first-class pharmaceutical contract micronization, milling and analytical services.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Particle Size Reduction & Micronization

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CLINICAL PACKAGING - BLISTER

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Catalent offers various clinical trial manufacturing & packaging services including formulation development. It also offers primary packaging services including blisters and HDPE bottles.

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Pharma Service: Packaging

Category: Clinical Services

Sub Category: Blister

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CLINICAL STORAGE & DISTRIBUTION

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