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Alcami Corporation

Company Headquarters

2320 Scientific Park Drive
Wilmington, NC 28405
United States

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Company Description

Alcami is a contract development and manufacturing organization, headquartered in NC with over 40 years experience, serving pharma and biotech companies of all sizes across the development lifecycle, providing services small molecules and biologics, providing customizable cGMP storage, environmental monitoring, and pharmaceutical support services.

Contract Service Directory

Content From Alcami Corporation

Clinical Trial Materials

Pharmather Engages Alcami For Clinical And Commercial Manufacturing Of Novel Ketamine Products

Alcami to manufacture PharmaTher’s proprietary ketamine products for FDA Phase 3 clinical studies and global commercialization.

News Releases Released on 11.08.2021
Promotions & Moves

Alcami Announces Parenteral Operations Leadership Appointments

Chad Bovero, James Fife, and Tobin Cowart promoted to senior leadership team.

News Releases Released on 11.08.2021
Drug Development | Formulation Development

Alcami Expands Parenteral Operations With Additional Investment

A $31 million investment will expand its sterile development and manufacturing operation in Charleston, SC.

News Releases Released on 11.08.2021
Promotions & Moves

Alcami Appoints Timothy Compton As Chief Business Officer

25-year industry professional brings a track record of leading high-performing, client-centered business teams.

News Releases Released on 11.08.2021
Formulation Development

CASE STUDY: OSD FORMULATION DEVELOPMENT

Alcami used a Gerteis Mini-Pactor® roller compactor to develop a capsule formulation and critical processing parameters at the target dosage in record time.

Case Studies Released on 11.08.2021
Formulation Development

Tryp Therapeutics Partners with Alcami for Proprietary Formulations

The agreement represents another step toward the proprietary manufacturing, formulation, and delivery of products for Tryp’s PFNTM program.

News Releases Released on 06.28.2021
Analytical Services | Biologics, Proteins, Vaccines | Extractables and Leachables

On-Demand Lab Open House

Sign up to get a close-up look at our US network of laboratories and hear about our expansion plans.

News Releases Released on 06.28.2021
APIs | Drug Development | Formulation Development

QBD Addresses API Supply in Orphan Drug Formulation

Due to the high costs and low demands of the drug product, it is important to efficiently use API supply during the formulation process.

Case Studies Released on 06.28.2021
Microbiology

On-Demand Webinar: Microbial In-Use Studies

In this webinar, Alcami’s Brent Harlow will guide you through the necessity of these studies and how to successfully perform them for FDA approval.

News Releases Released on 06.28.2021
Analytical Services | Bioassay Development | Biologics, Proteins, Vaccines | Drug Development

Host Cell Impurities, Bioassays, Micro-Flow Imaging

WHO, FDA and the European Pharmacopoeia have established strict regulatory guidelines to guarantee product quality in biologics.

White Papers / Tech Papers Released on 06.28.2021
Promotions & Moves

Alcami Appoints Patrick D. Walsh as Chairman and Chief Executive Officer

He succeeds Walter J. Kaczmarek III, who is stepping down as Chief Executive Officer.

News Releases Released on 03.18.2021
Combination Products & The CDMO Webinar - Watch Now On-Demand

During this webinar, regulatory and quality experts from Alcami provided insights into combination products and the latest regulatory guidance.

Videos Released on 03.04.2021
Pharmaceutical and Biotherapeutic Development and Testing

Formulation and Method Development.

Literature / Brochures Released on 01.13.2021
Drug Product Development, Manufacturing, and Packaging

Parenteral Forms.

Literature / Brochures Released on 01.11.2021
The Alcami Advantage

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Literature / Brochures Released on 01.08.2021

Related Content

Contracting And Outsourcing Exhibitor List

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09.11.23
APIs | Solid Dosage/Creams/Ointments

Spray Drying: A Proven Approach to Enhance the Solubility of APIs

Spray drying is an established particle engineering technology that offers several advantages over other methods used for improving API bioavailability.
Benzion Dolitzky, PhD, VP R&D, Wavelength Pharmaceuticals 09.09.21
APIs | Clinical Trial Materials

Outsourcing the Manufacture of Clinical Trial APIs

What to consider when deciding to partner with a CDMO for manufacturing.
Josh Hoerner, General Manager, Purisys 09.09.21
Logistics | Supply Chain

Maintaining Critical Drug Supply During COVID-19

Vincent Colicchio from Dr. Reddy’s talks about the challenges and solutions of maintaining supply during the pandemic.
Tim Wright, Editor, Contract Pharma 09.09.21
Analytical Services | Bioanalytical Services

Putting Laboratory Suppliers to the Test in the COVID Era – and Beyond

Build resiliency into analytical methods through careful consideration of chromatography partners.
Hazel Dickson, PhD, Marketing Manager, Chemistry Group, Waters Corporation 09.09.21
Choosing and Managing a CDMO

Speed up your time-to-market, keep development costs under control and smooth the FDA approval and commercial launch process.
Dana Toops, President, Avema Pharma Solutions 09.09.21
Breaking News | Facilities | Industry News

Xellia’s Cleveland Manufacturing Facility is Commercially Operational

Site producing key anti-infective drug products for U.S. hospitals and patients.
08.20.21
APIs | Breaking News | Facilities | Industry News

Curia to Expand U.S. Commercial Manufacturing Capability

Roughly $35 million will be invested to expand manufacturing and product-handling solutions for complex small molecules.
08.19.21
APIs

Generic APIs Portfolio

With almost 50 years of expertise in peptide and small molecule synthesis, Bachem has an outstanding track record in large-scale manufacturing.
Breaking News | Promotions & Moves

Alcami Appoints Timothy Compton Chief Business Officer

Mr. Compton brings more than 25 years of industry experience leading high-performing business teams.
08.10.21
Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News

Marvel Biotechnology Begins cGMP Manufacturing of Lead Candidate

Enters manufacturing agreement with Ausun Pharma for lead asset MB-204.
07.22.21
APIs | Breaking News | cGMP Manufacture | Industry News

MediPharm Labs Receives Canadian GMP Pharmaceutical DEL

License can be used for manufacturing, testing and sale of APIs and pharmaceutical drug products containing cannabis.
07.15.21
APIs | Breaking News | GMPs/GCPs | Industry News | QA/QC

Purisys Obtains Two Global ISO Certifications

Now certified for ISO 17025 for Testing and Calibration Laboratories and ISO 17034 for Reference Material Producers.
07.08.21
Breaking News | Collaborations & Alliances | Facilities | Industry News

WuXi STA Chooses Middletown Delaware for New Pharma Manufacturing Campus

The CDMO is bringing about 500 jobs to Middletown, with site expected to open in 2024.
06.29.21
Analytical Services | Bioassay Development | Biologics, Proteins, Vaccines | Drug Development

Host Cell Impurities, Bioassays, Micro-Flow Imaging

WHO, FDA and the European Pharmacopoeia have established strict regulatory guidelines to guarantee product quality in biologics.
Microbiology

On-Demand Webinar: Microbial In-Use Studies

In this webinar, Alcami’s Brent Harlow will guide you through the necessity of these studies and how to successfully perform them for FDA approval.
APIs | Drug Development | Formulation Development

QBD Addresses API Supply in Orphan Drug Formulation

Due to the high costs and low demands of the drug product, it is important to efficiently use API supply during the formulation process.
Analytical Services | Biologics, Proteins, Vaccines | Extractables and Leachables

On-Demand Lab Open House

Sign up to get a close-up look at our US network of laboratories and hear about our expansion plans.
Formulation Development

Tryp Therapeutics Partners with Alcami for Proprietary Formulations

The agreement represents another step toward the proprietary manufacturing, formulation, and delivery of products for Tryp’s PFNTM program.
APIs | Supply Chain

Maintaining Critical Drug Supply During the Pandemic

Vin Colicchio from Dr. Reddy’s talks about the challenges and solutions of maintaining supply during the pandemic.
Tim Wright, Editor, Contract Pharma 06.17.21
Bio News | Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News

Revolo and Northway Biotech Enter Manufacturing Partnership

To manufacture novel binding immunoglobulin protein, ‘1805, to support phase 2 trials in rheumatoid arthritis and uveitis.
06.11.21
Breaking News | Industry News

Biovectra Inc. Unveils New Logo and Brand

New image reflects the growing company’s full suite of expertise and core values.
Charles Sternberg, Assistant Editor 06.03.21
APIs | Breaking News | cGMP Manufacture | Industry News

Onyx Scientific Receives Commercial API License for UK Facility

Allows Onyx to support API projects from pre-clinical studies to low volume commercial manufacture.
Charles Sternberg, Assistant Editor 06.03.21
APIs | Cytotoxics and High Potency Manufacturing | Formulation Development | Process Development

Solubility Enhancement of Hydrophobic Drugs and APIs Using Hot Melt Extrusion

Efficient processing and production technology for solid molecular dispersion, HME can provide sustained, modified and targeted drug delivery.
Ameya Deshpande, Formulation Scientist, Avomeen 05.25.21
Breaking News | Cytotoxics and High Potency Manufacturing | Facilities | Industry News

Novasep Expands HPAPI Manufacturing Capacity

Responds to increasing customer demand for manufacturing services for antibody drug conjugates.
Tim Wright, Editor, Contract Pharma 05.13.21
Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

OncoTEX, Sterling Pharma Sign Clinical Mfg. Pact

Sterling will produce clinical material for OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.
Kristin Brooks 05.10.21
Breaking News | Industry News

Revolo Biotherapeutics, CordenPharma Enter Master Service Agreement

Will scale up and manufacture ‘1104 for the treatment of eosinophilic esophagitis and allergic disease.
Charles Sternberg, Assistant Editor 04.19.21
Analytical Services | APIs | cGMP Manufacture | Excipients | Formulation Development | QA/QC | R&D | Solid Dosage/Semi-solids

Enteris BioPharma: Custom Solutions – From Bench to Market

CDMO operations are housed within a 32,000-square-foot, FDA-inspected and cGMP-compliant facility in northern New Jersey.
Breaking News | Industry News | Promotions & Moves

Alcami Names Patrick D. Walsh as Chairman and CEO

35-year pharmaceutical industry veteran brings deep industry expertise and a track record of building successful, client-centric, growth organizations.
Tim Wright, Editor, Contract Pharma 03.19.21
Promotions & Moves

Alcami Appoints Patrick D. Walsh as Chairman and Chief Executive Officer

He succeeds Walter J. Kaczmarek III, who is stepping down as Chief Executive Officer.
Breaking News | Capsules | Industry News

CapsCanada Launches Liquid-Filled Hard Capsule Mfg. Service in North America

New service aims to return pharmaceutical and OTC drug manufacturing back to North America.
Kristin Brooks 03.10.21
Combination Products & The CDMO Webinar - Watch Now On-Demand

During this webinar, regulatory and quality experts from Alcami provided insights into combination products and the latest regulatory guidance.
Breaking News | Collaborations & Alliances | Industry News

Phlow Corp. and USP Form Alliance

Focused on continuous manufacturing to increase supply of essential medicines for U.S. patients.
Tim Wright, Editor, Contract Pharma 03.01.21
COVID-19 Impact Report

Leaders across the pharmaceutical contract services industry reflect on the impact of COVID-19 in 2020, and what to expect in 2021.
Tim Wright, Editor, Contract Pharma 01.27.21
Breaking News | Formulation Development | Industry News | Methods Development

Adare Pharma Solutions Opens New Small-Scale Lab

Vandalia, OH lab offers customizable, flexible systems designed to expedite formulation and process development services.
Kristin Brooks 01.26.21
Breaking News | Facilities | Industry News | Injectables | Parenterals

Civica to Build an Essential Medicines Manufacturing Facility in Virginia

Will produce sterile injectable meds used in hospitals for COVID-19 patient care.
Tim Wright, Editor, Contract Pharma 01.25.21
APIs | Breaking News | Facilities | Industry News

Sanofi Unveils EUROAPI as Name of New European API Company

Appoints Karl Rotthier as its future Chief Executive Officer.
Contract Pharma Staff 01.15.21
Pharmaceutical and Biotherapeutic Development and Testing

Formulation and Method Development.
Drug Product Development, Manufacturing, and Packaging

Parenteral Forms.
The Alcami Advantage

...
Alcami Expands Oral Solid Capabilities with Investment in Wilmington, NC

...
The Importance of Food Studies in Pharmaceutical Development

Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients.
RTP Formulation & Sterile Fill-Finish Facility

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ICP-MS - Leveraging Inductively Coupled Plasma Mass Spectrometry To Its Full Potential

by Chris Williams, Julia Spraul (pictured), and Alyssa McBurney
Breaking News | Cytotoxics and High Potency Manufacturing | Drug Delivery | Facilities | Industry News

Inhalation CDMO Vectura Expands HPAPI Capabilities

New facility will increase containment operations at Chippenham, UK site.
Contract Pharma Staff 12.14.20
Breaking News | Cold Chain Management | Facilities | Industry News | Logistics | Supply Chain

Logistics4Pharma Facility Passes Inspection

German logistics firm completes validation of GDP cold chain storage and transportation at Frankfurt facility.
Contract Pharma Staff 12.09.20
APIs | Breaking News | cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News

Piramal Invests $32M to Expand Michigan Facility

Includes additional capacity in Potent and Non-Potent API development and manufacturing.
Contract Pharma Staff 12.08.20
Breaking News | Drug Development | Promotions & Moves

NeuBase Therapeutics Appoints Chief Scientific Officer

Dr. Curt Bradshaw brings decades of experience in successfully delivering genetic medicines to clinics.
Contract Pharma Staff 12.02.20
Bio News | Breaking News | Collaborations & Alliances | Industry News

Samsung Biologics Partners with Eli Lilly

Accelerates the delivery of Covid-19 antibody treatments.
Contract Pharma Staff 11.20.20
Excipients

Pharmaceutical Excipients Market Poised for Growth

The global pharmaceutical excipients market is estimated to surpass $11,944.6 million by 2027.
Contract Pharma Staff 11.03.20
Breaking News | Industry News

Lilly, U.S. Govt. Enter Supply Pact for Bamlanivimab COVID-19 Treatment

Initial agreement is for 300,000 vials of the investigational neutralizing antibody with potential for purchase of an additional 650,000 vials.
Contract Pharma Staff 10.28.20
Breaking News | Facilities | Industry News

Sterling Pharma Solutions Opens Material Science Center

Offers specialist solid state chemistry and milling services.
Contract Pharma Staff 10.06.20
APIs | Breaking News | Facilities | Industry News

Sterling Pharma Solutions Expands US Operations

Acquires Alcami’s Germantown, WI API facility.
Contract Pharma Staff 10.02.20
Breaking News | Industry News | Promotions & Moves

Alcami Makes Senior Leadership Appointments

Sally Langa to lead biz dev efforts; Kimberly McClintock returns to head-up marketing
Contract Pharma Staff 05.08.20
Process Development for Scaled-up hESC/hiPSC Manufacturing

An optimized 14-day manufacturing workflow which produces > 10^10 , cells was developed in < 12 months
APIs | Breaking News | cGMP Manufacture | CRO News | Drug Development | Facilities | Industry News

Alcami Sells Netherlands Site to MerachemSyncom

Expands portfolio of chemistry services from compound design to clinical proof of concept.
01.09.20
Breaking News | cGMP Manufacture | Drug Development | Industry News | Process Development

Alcami to Expand Charleston Ops

$17 million investment will add 6,000 sq.-ft., substantially augmenting capacity for sterile drug product development and manufacturing
12.19.19
Breaking News | Industry News | Promotions & Moves | Solid Dosage/Creams/Ointments

Bora Names President of North American Ops

Sam Ricchezza to lead the Taiwan-based CDMO’s North American push.
11.20.19
Frontage Laboratories' Hugh Davis

Frontage's chief business officer highlights the CRO's service offerings.
Contract Pharma Staff
Catalent's Stacey Treichler

Catalent's product manager for biologics highlights key events.
Contract Pharma Staff
Tedor Pharma’s Terry Novak

Tedor Pharma's chief operating officer highlights company capabilities.
Contract Pharma Staff
Alcami's Brittany Jackway

Alcami's senior manager for sales and business development talks with Contract Pharma.
Contract Pharma Staff
cGMP Manufacture | Drug Development

Contract Pharma’s 20th Anniversary Series: CDMO Insight

JoyL Silva of Pfizer CentreOne discusses global market and regulatory changes driving drug development strategies and the evolution of CDMO services and ops.
Kristin Brooks, Contract Pharma 11.01.19
Formulation Development: New Challenges, Approaches, and Solutions

...
10.28.19
Contract Pharma’s 18th Conference & Tabletop Exhibit Was a Another Success!

Contracting & Outsourcing 2019 featured a sold-out exhibit hall and lively conference sessions.
10.22.19
Breaking News

Contract Pharma’s 18th Conference & Tabletop Exhibit Was a Another Success!

Contracting & Outsourcing 2019 featured a sold-out exhibit hall and lively conference sessions.
10.18.19
Contract Pharma’s 20th Anniversary Retrospective

A look back a the pharma/biopharma industry and the future of outsourcing.
Kristin Brooks, Managing Editor, Contract Pharma 10.15.19
Breaking News | Industry News | Microbiology

Alcami Launches Rapid Sterility Offering

New Milliflex Rapid System is housed in Alcami's Wilmington, NC advanced analytical testing technology center
10.09.19
Regulatory Affairs | Serialization

Fighting Back!

The drug industry takes a bare-knuckle approach to drug counterfeiters.
Daniela Geiger, Vetter 10.04.19
Breaking News | Industry News

VIDEO: Alcami's Brittany Jackway

Alcami's senior manager for sales and business development talks with Contract Pharma.
10.02.19
VIDEO: Contract Pharma 2019 Video Highlights!

Contracting & Outsourcing 2019 featured a sold-out exhibit hall and lively conference sessions.
10.02.19
Breaking News | Industry News | Solid Dosage/Creams/Ointments | Solid Dosage/Semi-solids

Upperton Pharma Solutions Investment Increases Tabletting Capabilities

New Futorque X tablet press is designed to support R&D studies and production batches
09.16.19
Breaking News | Industry News | Inspections

Bora Secures FDA Approval for CDMO Services

Reports successful inspection of Zhunan, Taiwan site
09.03.19
Preparing for Your CDMO Selection Process

Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing.
Industry News | Serialization

Legacy Pharmaceuticals Advances New Russian Track and Trace Regulation

Regulation sets new bar for serialization, compliance reporting, and data management
07.23.19
4th Annual Congress on Regulations and Compliance for Cosmetics

...
07.18.19
QA/QC | Validation

Considerations for Analytical Method Validation Lifecycle Controls

ICH is set to implement new regulatory guidance dedicated to analytical method development
Paul Mason, PhD, Lachman Consultants 07.15.19
Schreiner MediPharm Introduces Product for Double Tamper Protection

Multi-Tear Closure Label, equipped with security effects to prevent undetected opening of pharmaceutical packaging
07.10.19
Breaking News | Facilities | Industry News

Wasdell Begins Operations at EU HQ

90,000 sq. ft. facility features 11 production suites, temperature controlled warehouses
07.05.19
Clinical Trials | GMPs/GCPs | QA/QC | Regulatory Affairs

Good Clinical Practice: Serious Breach Process

How to assess the significance of the breach, who needs to be involved, and how to report it
Jane Wood, Principal, YourEncore Quality Center of Excellence 06.27.19
Solid Dosage/Creams/Ointments

Oral Solids Endure & Evolve

Contract Pharma talks with several contract service providers about the state of the oral solid dose development and manufacturing market.
Tim Wright, Editor, Contract Pharma 03.06.19
Breaking News | Collaborations & Alliances | Industry News

Alcami Collaborates with Medicines Development for Global Health

Helps the not-for-profit secure FDA approval of moxidectin for river blindness
10.26.18
Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News

Alcami, UNCW Awarded $1.12M Biomfg. Grant

Project Call 1.0 proposal selected by NIIMBL governing committee
08.31.18
Bio News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News

Alcami Extends Workbench Laboratory Services Program

To support the ongoing manufacturing and development of ZILRETTA for Flexion Therapeutics
06.13.18
Breaking News | Industry News

Alcami Acquired by Private Equity Firm

The CDMO's management team will remain in place
06.01.18
Bio News | Breaking News | Facilities | Industry News

Alcami To Be Honored for Operational Excellence

Missouri House of Representatives and St. Louis Mayor Lyda Krewson will present a resolution and letter of commendation
05.07.18
Alcami Donates $10K to TROSA

The gift will fund TROSA's technology needs for its recently established Comprehensive Care Center
03.15.18
Industry News

Alcami Opens Office in Cambridge, MA

Kendall Square facility will be a hub for Alcami's global sales and business development organization
02.13.18
Industry News

Alcami Expands to West Coast

The office will feature the company's virtual experience, granting customers access to Alcami facilities and team members
11.16.17
APIs | cGMP Manufacture | Clinical Trial Materials | Industry News

Alcami, Solasia Enter API Mfg. Pact

To manufacture Solasia's Darinaparsin API at CoE in Germantown, WI
11.09.17
Industry News

Alcami Opens International Sales Office in Tokyo

Provides a home base for local customers interested in developing and manufacturing products for launch in the U.S.
10.19.17
APIs | Breaking News | Facilities | Industry News

Alcami to Establish API Center of Excellence

Demand for end-to-end services spurs decision to expand
09.07.17
Drug Development | Industry News

Alcami, UNCW Partner on Courses for Pharmaceutical Sciences

Aims to provide students with an overview of the drug development process from concept to commercialization
07.28.17
Breaking News | Facilities | Industry News

Alcami to Move HQ

Plans call for the relocation of global headquarters to Research Triangle Park in 2018
07.17.17
Analytical Services | Drug Development | Fill/Finish | Industry News | Lyophilization

Alcami Invests $5M to Expand SC Ops

Will continue to expand its filling and freeze-drying capabilities
05.04.17
cGMP Manufacture | Drug Development

Alcami Introduces OnDemand Customer Portal Application

Aims to allow clients rapid access and visualization into their ongoing projects
03.27.17
Analytical Services | Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News

Alcami Expands Analytical Capabilities

Invests in Bruker's D8 Discover HTS System for high-throughput X-Ray diffraction screening
03.06.17
Promotions & Moves

DCAT Appoints 2016, 2017 Officers

Boyer of AMRI to serve as president
10.31.16
Breaking News | Industry News | Supply Chain

Alcami Launches Supply Chain Solution

Aims to support a backup supply option for potential clinical, launch and commercial supply
10.05.16
APIs | Breaking News | Facilities | Industry News

Alcami Expands Highly Potent API Capabilities and Capacity

Will enhance Germantown, WI, facility to introduce the development and manufacturing of highly potent APIs
08.15.16
APIs | Cytotoxics and High Potency Manufacturing | Industry News

Alcami to Add HPAPI Capabilities

Two new cGMP production suites will focus on primary containment technologies at Germantown, WI facility
08.12.16
Breaking News | Industry News

Alcami Expands Service Capabilities at Four U.S. Sites

Invests in MicroSEQ Rapid Microbial Identification System
05.13.16
Photos from INTERPHEX Show Floor

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05.04.16
APIs | Chemistry | Formulation Development | Lyophilization

AAI/CML Becomes Alcami

New brand and identity provides an integrated offering for both drug substance and drug product
04.26.16
APIs | Breaking News | cGMP Manufacture | Chemistry | Clinical Trial Materials | Drug Development | Drug Discovery | Fill/Finish | Formulation Development | Industry News | Lyophilization | Parenterals | Solid Dosage/Creams/Ointments

AAI/CML Becomes Alcami

New brand and identity provides an integrated offering for both drug substance and drug product
03.16.16