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Kemwell Biopharma

Company Headquarters

511 Davis Drive, Suite 100, Morrisville, NC, 27560, US

Driving Directions Phone: View Phone Fax: View Fax
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Categories from Kemwell Biopharma

505(b)(2)
Accelerated Stability Studies
Aerosol Filling
Analytical Laboratory Services
Analytical Methods Development
Analytical Validation Studies
Animal Health
Aseptic Processing
Assay Development
Biological Testing
Biologics Manufacturing
Biologics Process Development
Bioprocess Validation
Bioprocessing
Bioprocessing, Disposable/Single-Use
Biosimilars
Blending
Cell Culture Media Development
Chiral Separations, R&D
Chromatographic Analysis, LC/GC
Chromatography
Clean in Place / Sterilization in Place (CIP/SIP)
Clinical Analysis
Clinical Supply Management
Clinical Trials, Phase III
CMC (Chemistry, Manfacturing & Controls)
Coating & Lamination
Comparator Drug Blinding
Comparator Drug Purchasing
Contract Development and Manufacturing Organization (CDMO)
Contract Manufacturing
Contract Packaging
Contract Research
Dosage Form Development
Downstream Processing
Drug Development Services
Encapsulation
European QP
Fermentation
Filling, Capsule
Filling, Syringe
Filling, Vial
Fluid Bed Processing
Forced Degradation Studies
Formulation Development
Formulation Services
Formulation, Controlled Release
Granulation
HPLC
In Vitro Testing
IND/NDA Submissions
Lot Release Testing
Lyophilization
Mammalian Cell Culture
Manufacturing, Aseptic Fill/Finish
Manufacturing, Bioequivalence
Manufacturing, Biologics
Manufacturing, Capsules
Manufacturing, Clinical Trials Supply
Manufacturing, Controlled Substances
Manufacturing, Creams & Ointments
Manufacturing, Dose Form, Non-Sterile
Manufacturing, Dose Form, Sterile
Manufacturing, Ethical
Manufacturing, Gels
Manufacturing, Generics
Manufacturing, Injectables
Manufacturing, Liquids
Manufacturing, Lyophilized Products
Manufacturing, Oral Drug Delivery
Manufacturing, Orally Dispersible Tablet
Manufacturing, OTC
Manufacturing, Other
Manufacturing, Parenterals, Small Volume
Manufacturing, Peptides
Manufacturing, Powders, Non-Sterile
Manufacturing, Powders, Sterile
Manufacturing, Proteins
Manufacturing, Semisolids
Manufacturing, Solid Dosage
Manufacturing, Solutions & Suspensions
Manufacturing, Suppositories
Manufacturing, Sustained Release
Manufacturing, Syringes, Pre-filled
Manufacturing, Tablets
Manufacturing, Topicals
Mass Spectrometry
Methods Development
Methods Validation
Micro FT-IR Analysis
Microbiological Testing
Mixing & Blending
Mixing and Granulating Equipment
Packaging, Blister
Packaging, Blister, Cold Form
Packaging, Capsules
Packaging, Clinical Trial Materials
Packaging, Clinical Trials
Packaging, Creams & Ointments
Packaging, Injectables
Packaging, Liquids
Packaging, OTC
Packaging, Parenterals
Packaging, Solid Dosage
Parenterals Development
Parenterals, Syringe Filling
Parenterals, Vial Filling
Particle Characterization
Particle Size Analysis
Photostability
Pilot-Scale Filling
Polymerase Chain Reaction
Preformulation
Process Characterization
Process Development/Scale-Up Services
Process R&D
Process Validation Studies
Project Management
Protein Extraction/Purification
Protein Synthesis
Purification
QA/QC
Quality Control Testing
R&D Services
Raw Materials Analysis
Scale-Up
Serialization
Spray Drying
Stability Studies
Stability, ICH
Sterile Filling
Sterility Testing
Sterilization
Storage
Syringe Filling
Tablet Coating
Technology Transfer
Transdermals/Transmucosals
UV-VIS Spectrophotometer Analysis
Validation, Equipment Cleaning
Validation, Filtration
Validation, Manufacturing

White Papers / Tech Papers

Selecting a Dosage Form for Drug Delivery to the Lungs

When initiating a development program for drug delivery to the lungs, selection of the dosage form warrants careful consideration.

Released By Kemwell Biopharma

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Features

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Lilly leads this year’s Top 20 as major drugmakers expand U.S. manufacturing and prepare for more complex launches amid pricing pressure, patent cliffs and rising obesity demand.

By: Tim Wright

Breaking News

Kemwell’s Bengaluru Facility Completes U.S. FDA Inspection

This demonstrates the company’s ability to meet cGMP and aseptic drug-product manufacturing standards.

By: Rachel Klemovitch

Features

Big Pharma’s New Chapter: M&A, Metabolism & The Outsourcing Boom

A look at the shifting strategies and surging sectors reshaping the Top 20 drugmakers.

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Promotions & Moves

Centauri Therapeutics Names Debra Barker as Chief Medical Officer

Dr. Barker is an experienced clinical immunologist with broad executive experience across both big pharma and biotech.

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Features

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Online Exclusives

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Where big pharma stands in the face of nimble tech-driven start-ups, the impact of layoffs, and what we can expect from M&A in the future.

Collaborations & Alliances

RevOpsis, Kemwell Enter Manufacturing Partnership to Accelerate Development of RO-104

Collaboration leverages Kemwell's manufacturing excellence and RevOpsis' Rev-Mod platform to expedite the development of novel multispecific biologics.

Collaborations & Alliances

Kemwell BioPharma Implements Veeva QMS

Aims to drive quality excellence across its development and manufacturing operations with the cloud-based platform.

Collaborations & Alliances

Cipla, Kemwell Biopharma, Manipal Form Cell Therapy JV

Aims to expedite development, manufacturing, licensing, import and export of cell therapy products.

Promotions & Moves

Curevo Vaccine Names Guy De La Rosa Chief Medical Officer

Brings 20 years of big pharma and biotech infectious disease clinical trial experience.

Back Page

Big Pharma Expands R&D Base in India

Offshoring to support drug development.

By: Soman Harachand

Promotions & Moves

Avalyn Pharma Appoints Lyn Baranowski CEO

Ms. Baranowski brings more than two decades of experience leading a vast array of functions in biotech, big pharma and venture capital firms.

White Papers / Tech Papers

Why is Big Pharma Increasingly Adopting 505(b)(2)?

USFDA 505(b)(2) pathway submissions (“(b)(2)s”) can be advantageous because they offer the potential for the accelerated approval of patient-centric medicines.

Breaking News

Recipharm Secures Vaccine Manufacturing Deal

Inks deal with top 10 big pharma and will provide manufacturing support from facility in Kaysersberg, France.

Collaborations & Alliances

Cipla, Kemwell Enter Biosimilars Joint Venture

Partnership to focus on developing, manufacturing and commercializing biosimilars.