Lyne Laboratories

What Lyne Laboratories does

Lyne Laboratories is a privately held pharmaceutical contract development and manufacturing organization (CDMO) founded in 1965 and headquartered in Brockton, Massachusetts. The company specializes in oral liquid dosage forms, unit-dose liquid packaging, powder technology, and compounding services for pharmaceutical clients. It operates a 100,000-115,000 square foot cGMP-compliant facility that includes nine packaging rooms, six compounding rooms, and eight filling lines with capacity up to 250 containers per minute, plus a specialized explosion-proof building for high-alcohol and solvent-based drug products. Lyne holds FDA registration, EPA registration, DEA licensing, and ISO 9001:2000 certification, enabling it to handle scheduled drugs and high-concentration flammable formulations.

Lyne generates revenue through contract manufacturing services (compounding, filling, packaging, and analytical/regulatory services) on a project or quote-based pricing model. Its customer base spans large ethical pharmaceutical companies, mid-size pharma firms, small biotech start-ups, and virtual pharmaceutical companies that outsource manufacturing. In 2013, Lyne expanded beyond pure contract services into proprietary generic pharmaceuticals via an Abbreviated New Drug Application (ANDA) program, which has since supported more than 20 ANDA submissions. The company pursues strategic partnerships with firms that have strong commercialization capabilities to jointly launch the ANDA products it develops.

The company has executed a multi-phase facility expansion (including a 50,000 sq ft expansion completed in 2012 for flammable products) and opened a dedicated R&D center in 2016 to scale its generics pipeline. Lyne remains privately held under long-tenured leadership, with founder Dr. Robert Crisafi serving as Chairman and Stephen Tarallo as President and CEO. Key technical differentiators include its pioneering role in liquid unit-dose packaging and its specialized handling of flammable and controlled-substance drug products.

Name

Lyne Laboratories

Legal name

Lyne Laboratories

Website

https://lyne.com

Company type

Private

Founded year

1965

Operating status

Operating

Headcount range

11–50 employees

Short description

Lyne Laboratories is a privately held pharmaceutical CDMO in Brockton, MA that provides contract manufacturing, development, analytical, and regulatory services for oral liquids, powders, and unit-dose packaging to large pharma, mid-size pharma, biotech, and virtual pharma clients.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834), Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI)

Keywords

• Pharmaceutical contract manufacturing
• ANDA drug development
• Unit-dose packaging
• Pharmaceutical compounding services
• CGMP manufacturing services

Headquarters

HQ city

Brockton

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Supply Chain, Marketing or Sales

Revenue model

1. Contract Manufacturing Services: Lyne provides contract manufacturing services to pharmaceutical companies, offering compounding, filling, and packaging services for oral liquids, powders, semi-solids, tablets, and unit-dose liquid packaging. Services include clinical manufacturing (late stage Phase III), technical transfer, commercial manufacturing, analytical services, ICH stability programs, validation services, and regulatory support for NDAs and ANDAs.
2. Proprietary Generic Pharmaceuticals: Lyne develops and manufactures ANDA (Abbreviated New Drug Application) generic drugs independently or in conjunction with partners. The company pursues partners to carry out the launch and commercialization of the ANDA drugs it develops.
3. Scheduled Drugs and Alcohol Formulations: Lyne offers manufacturing services for controlled substances and high-alcohol content or solvent-based drug products in their specialized explosion-proof facility.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

Lyne Laboratories is a pharmaceutical contract development and manufacturing organization (CDMO) that produces oral liquid, powder, semi-solid, and tablet dosage forms, with a specialization in liquid unit-dose cup packaging and powder technology. It offers compounding, filling, packaging, analytical, regulatory, and pre-formulation/formulation development services, and also develops and manufactures proprietary ANDA generic drugs from a cGMP-compliant facility in Brockton, Massachusetts.

Product overview

Lyne Laboratories is a privately held pharmaceutical contract manufacturing organization (CMO) with over 35 years of experience, offering a comprehensive suite of drug development and manufacturing services from its cGMP-compliant 100,000+ square foot facilities in Brockton, Massachusetts. The company's core offerings include contract manufacturing services (compounding, filling, and packaging), development services (pre-formulation through regulatory support), analytical services, and regulatory services. Lyne specializes in oral liquids, powders, semi-solids, tablets, and liquid unit-dose packaging, with additional capabilities for scheduled drugs and alcohol formulations. The company has expanded beyond pure contract manufacturing to include proprietary generic pharmaceuticals development, supported by a new R&D center opened in 2016.

Differentiator

Problem solved

Functional benefit

Products and services

• Contract Manufacturing Services Full-service pharmaceutical contract manufacturing services including clinical manufacturing (late-stage Phase III), commercial manufacturing, and technical transfer for oral liquids, powders, semi-solids, and tablets, targeted at pharmaceutical companies needing compliant production capacity.
• Compounding Services Small and large volume batch compounding for liquid dosage forms (solutions and suspensions), semi-solids (ointments, gels, lotions), solid dosage forms (powders and capsules), controlled substances, and high alcoholic content products, with batch sizes ranging from 100L pilot scale to 10,000L commercial scale.
• Filling and Packaging Services Liquid, semi-solid, and solid dosage form filling and packaging including liquid bottling (3ml to 500ml at up to 225 bottles/minute), tube filling (up to 65 tubes/minute), and solid bottling (2g to 500g at up to 100 bottles/minute).
• Liquid Unit-dose Packaging Turn-key liquid unit-dose packaging service in which Lyne pioneered the format, offering start-to-finish manufacturing and repackaging with various cup materials, shrink-wrapped 10-cup trays, and packaged 100 cups per shipper, used for hospital medications and pediatric/geriatric patient compliance.
• Analytical Services Quality control and analytical testing laboratory offering method transfer, method validation, microbiological services, cleaning validation, ICH-condition stability services, monograph testing, API testing, and component and drug product testing.
• Regulatory Services Regulatory and compliance support including CMC section preparation, cGMP compliance, document control, regulatory professional certification, and management of FDA pre-approval and post-validation inspections for NDA and ANDA submissions.
• Drug Development Services Pre-formulation and formulation development, process development and scale-up, analytical method development and validation, stability studies, regulatory support, and pilot and engineering batches for partners developing new or generic drug products.
• Proprietary ANDA Generic Pharmaceuticals Independently developed and manufactured Abbreviated New Drug Application (ANDA) generic drug products, with more than 20 ANDA submissions supported, commercialized alone or in partnership with companies possessing strong commercial capabilities in specific drug categories.

Quantifiable outcome

• Successfully supported more than 20 ANDA submissions since establishing dedicated generic pharmaceuticals R&D department
• +2 more outcomes

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Safecor HealthminorOthers · 1 January 2008Safecor Health acquired Regional Service Center, a company founded by Dr. Robert Crisafi (Lyne's Chairman). Regional Service Center was the pioneer business for outsourced unit-dose and bar code medication repackaging services for hospitals.

Scale indicators7 records

Recent moves15 records

Expansion highlights5 records

Direct peers

• Halo Pharmaceutical: Mid-size US CDMO with capabilities in oral solids, liquids, topicals, and ANDA development, similar size-tier and customer profile to Lyne. Comparable generic-pharma contract manufacturing focus.
• Pillar5 Pharma (formerly Phebra): US-headquartered CDMO focused on oral solid and liquid generics manufacturing. Direct overlap with Lyne on ANDA-stage oral products and shared target customer base of generic pharma sponsors.
• Mikart, Inc. US CDMO offering liquid, semi-solid, and solid dose contract manufacturing plus ANDA development support. Overlapping customer base of small/mid pharma and generic-drug sponsors.
• CoreRx, Inc. Florida-based CDMO providing formulation development and manufacturing for oral liquids, suspensions, and semi-solids. Comparable mid-size contract-manufacturing profile with regulatory and analytical services.
• Pharmasol: US-based contract development and manufacturing organization focused on semi-solid, liquid, and powder dosage forms. Highly comparable to Lyne given the shared specialty in liquids, ointments/gels, and powder blending for pharma clients.
• Tedor Pharma: Contract development and manufacturing organization specializing in oral solid and liquid dosage forms with small-batch flexibility. Direct competitor for Lyne, and notably referenced in Lyne management bios as a prior employer of senior leaders.
• Alcami Corporation: Mid-size US CDMO providing parenteral and oral solid/liquid manufacturing plus analytical and packaging services. Comparable tier of mid-market CDMOs serving branded and generic pharma.

Broad incumbents

• Patheon (Thermo Fisher Scientific): Large global CDMO within Thermo Fisher providing integrated drug substance, drug product, and packaging services for oral solids, liquids, and sterile products. Represents the scaled incumbents Lyne competes against for enterprise contracts.
• Aenova Group: European-headquartered CDMO with broad solid, semi-solid, and liquid dose manufacturing capabilities. Overlaps with Lyne in oral liquids and generics contract manufacturing, but at significantly larger scale and global footprint.

Emerging players

• Lannett Company, Inc. US generic pharmaceutical manufacturer with its own ANDA portfolio and contract manufacturing exposure. Comparable as a generic-pharma ANDA operator, though vertically integrated downstream rather than purely a CDMO.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/lyne-laboratories-inc.

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lyne Laboratories