Apozeal Pharmaceuticals

What Apozeal Pharmaceuticals does

Apozeal Pharmaceuticals Inc. is a US-based, privately held, founder-owned pharmaceutical manufacturer and contract development and manufacturing organization (CDMO) that was established in 2022 through the acquisition of Torrent Pharma's Levittown, Pennsylvania facility and product portfolio. The site is a 75,000 sq. ft. US FDA-registered, cGMP-compliant manufacturing facility with DEA Schedule II-V controlled substance authorization, and the company inherited 10 FDA-approved ANDA products plus additional ANDAs filed and under development. Core manufacturing capabilities cover oral liquid solutions, suspensions, and suppositories, supported by a fully equipped analytical laboratory (4 Agilent GC, 20 HPLC/UPLC systems, FT-IR, ion chromatography, Karl Fischer titrators, Malvern particle size analyzer, and 11 stability chambers), serialization-capable primary and secondary packaging (including a new Prima K7 Blisterpack and Ready-to-Shelf liquids unit-dose line), and internal distribution operations based in Levittown serving the US pharmacy market.

The company runs a dual business model. First, it manufactures and sells its own FDA-approved generic pharmaceuticals to retail, hospital, long-term care, and community health center pharmacies across the United States — Hydroxyzine HCL Solution USP 10mg/5ml was launched as the first commercial SKU, with 9 additional approved ANDAs planned for near-term launch. Second, it offers CDMO and pharmaceutical development consultation services to small, mid-size, and large biopharma organizations, spanning formulation development, scale-up, technology transfer, process validation, analytical method development and validation, and regulatory/commercialization strategy support. Future strategic direction is articulated as diversification into solid orals, injectables, and biologics.

Revenue mechanics are not publicly disclosed, with generic product sales likely operating on standard pharmaceutical distribution economics (unit-volume margins with pharmacy-channel distribution) and CDMO revenue structured as project-based professional services. The company is bootstrapped and founder-financed, with ownership concentrated in two executives who together bring over 60 years of combined pharmaceutical experience spanning marketing, sales, distribution, R&D, commercial operations, and general management. The operating footprint is currently single-site and US-domestic only.

Name

Apozeal Pharmaceuticals

Legal name

Apozeal Pharmaceuticals Inc.

Website

https://apozealpharma.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

1–10 employees

Short description

Apozeal Pharmaceuticals is a US-based, founder-owned generic pharmaceutical manufacturer and CDMO operating a 75,000 sq. ft. FDA-registered, DEA-approved facility in Levittown, PA, with 10 approved ANDAs, CDMO services, and pharmacy distribution.

Ownership category

akta.pro rank

Product category

Generic Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Small-Molecule Generics (Branded/Unbranded) (HLAIABAA)

akta.pro secondary industries

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI), Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ)

Keywords

• Generic pharmaceuticals
• Contract manufacturing
• Oral liquid solutions
• ANDA drug development
• Analytical testing services

Headquarters

HQ city

Levittown

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Generic Pharmaceutical Product Sales: Revenue generated from manufacturing and selling FDA-approved generic pharmaceutical products (ANDA products) to the US market. The company has launched Hydroxyzine HCL Solution with additional products in the pipeline.
2. CDMO/Contract Manufacturing Services: Revenue from contract development and manufacturing services offered to pharmaceutical companies, including formulation development, scale-up, process validation, and analytical method development.
3. Pharmaceutical Development Consultation: End-to-end pharmaceutical development consultation services for clinical trial preparation, commercial manufacturing site selection, stability studies, process validation, and regulatory compliance.
4. Distribution Services: Distribution services to pharmacies including retail, hospital, long-term care, and community health center pharmacies.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

Apozeal Pharmaceuticals manufactures and sells FDA-approved generic pharmaceutical products (currently launching Hydroxyzine HCL Solution with 9 additional FDA-approved products in pipeline) directly to US pharmacies, and provides integrated CDMO services — formulation development, analytical testing, commercial manufacturing of oral liquids/suspensions/suppositories, packaging with serialization, distribution, and consultation — to other pharmaceutical companies from its 75,000 sq. ft. cGMP facility in Levittown, PA.

Product overview

Apozeal Pharmaceuticals is a US-based pharmaceutical company offering a portfolio of 10 FDA approved ANDA products, with multiple ANDAs filed and pending approval, and additional products under development. The company operates a 75,000 sq. ft. US FDA registered and DEA approved (Schedule II-V) manufacturing facility in Levittown, PA. Core product offering includes Hydroxyzine HCL Solution, USP 10mg/5ml as the first launched product, with 9 additional FDA approved products planned for near-term launch. The company provides integrated CDMO services encompassing research and development, analytical testing, manufacturing (oral liquid solutions, suspensions, suppositories), packaging (bottles, blisters, cartons with serialization), distribution, and pharmaceutical development consultation. Future diversification plans include solid orals, injectables, and biologics.

Differentiator

Problem solved

Functional benefit

Products and services

• Hydroxyzine HCL Solution, USP 10mg/5ml US FDA-approved oral liquid generic pharmaceutical product indicated for symptomatic relief of anxiety, management of pruritus due to allergic conditions, and as a sedative. Marketed in 1 Pint (473 mL) bottles and sold to US pharmacies.
• CDMO (Contract Development and Manufacturing) Services Contract development services for a variety of dosage forms as well as complex niche formulations, including bench-scale formulation development, scale-up, technology transfer, process validation and technical support, and analytical method development and validation. Targeted at small, mid-size, and large biopharma/pharmaceutical organizations.
• Research and Development Services
• Analytical Services
• Commercial Manufacturing Services
• Packaging Services
• Pharmaceutical Development Consultation Services
• Distribution Services

Named customers4 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Torrent PharmaacquisitionOthersApozeal Pharmaceuticals acquired the Torrent Pharma facility and products based in Levittown Pennsylvania, USA for an undisclosed sum. This acquisition included 10 approved ANDAs, many ANDAs filed and under review at US FDA, and additional ANDA products under development.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Glenmark Pharmaceuticals: India-headquartered global generic manufacturer with US commercial operations and approved ANDAs. Comparable as a generic manufacturer selling into the US market through pharmacies, but at significantly larger scale and with global footprint.
• Endo Pharmaceuticals: US-based specialty and generic pharmaceutical manufacturer with sterile injectables and oral solids manufacturing. Comparable in US generics/specialty positioning and in-house manufacturing capability, though at larger scale.
• Teva Pharmaceutical Industries: Largest US generics player by volume with broad portfolio across dosage forms and significant US manufacturing. Comparable as a US-market generics competitor but at vastly larger scale and broader product breadth.

Direct peers

• Upsher-Smith Laboratories: Private US-based generic and specialty pharmaceutical company with manufacturing in Minnesota. Comparable as a privately held, US-manufacturing-focused generics player with similar mid-scale profile.
• ANI Pharmaceuticals: US-based specialty generic pharmaceutical manufacturer that also operates a CDMO segment (ANI API and Novitium). Directly comparable to Apozeal's hybrid generic + CDMO business model and focus on niche/complex generics.
• Cambrex: Small-molecule API and finished dosage CDMO with multiple US and European facilities. Comparable as a small-molecule CDMO serving pharma customers with development, scale-up, and commercial manufacturing capabilities.
• Piramal Pharma Solutions: Global CDMO offering development and manufacturing services for small molecules across multiple dosage forms including oral liquids and injectables. Comparable as a CDMO competitor pursuing pharma customers needing development + commercial-scale manufacturing.
• Amneal Pharmaceuticals: US-based generic and specialty pharmaceutical manufacturer with significant in-house manufacturing and an injectables franchise. Comparable as a vertically integrated US generics manufacturer with growing specialty/CDMO exposure.
• Lannett Company: US-based generic pharmaceutical manufacturer with a focus on affordable generics distributed through wholesalers and pharmacies. Comparable in scale, US manufacturing footprint, and commercial generics strategy.

Others

• Torrent Pharma: India-based generic manufacturer whose Levittown PA facility and 10 ANDAs were acquired by Apozeal. Not a current competitor but a strategic counterparty and former operator of the same asset.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/apozeal

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

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 Apozeal Pharmaceuticals