Harvest Moon Pharmaceuticals

What Harvest Moon Pharmaceuticals does

Harvest Moon Pharmaceuticals USA, Inc. is a privately held specialty pharmaceutical company founded in 2007 and headquartered in Falls Church, Virginia. The company develops, manufactures, and out-licenses complex generic drug products and biosimilars, operating a three-pronged portfolio: (1) complex generics spanning transplant drugs, injectables, transdermal patches, oral CR/XR formulations, inhalation products, and ophthalmic solutions; (2) biosimilars including EPO, filgrastim (G-CSF), PEG filgrastim, beta interferon 1a and 1b, insulin, insulin glargine, imiglucerase, enoxaparin, and etanercept; and (3) technology services such as high-performance stable cell lines, pedigreed cell lines for monoclonal antibodies (rituximab, bevacizumab, trastuzumab, infliximab, adalimumab, cetuximab), cDNA clones, protein reference standards, purification processes, and analytical tools including peptide mapping and glycan analysis.

The company's core technology centers on proprietary expression vectors with built-in selection markers that produce biosimilar proteins at levels exceeding traditional approaches, combined with fully pedigreed cell lines traceable to origin and analytical methodology for complex glycosylated protein characterization. Manufacturing is conducted through approved facilities in the US, EU, and through upgraded finished dosage partners in China, Taiwan, Japan, and Korea, with the German supply chain used for finished vial production of products such as G-CSF for less regulated markets.

Name

Harvest Moon Pharmaceuticals

Legal name

Harvest Moon Pharmaceuticals USA, Inc.

Website

https://harvestmoonpharma.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

1–10 employees

Short description

Harvest Moon Pharmaceuticals is a privately held Falls Church, Virginia-based specialty pharmaceutical company that develops, manufactures, and out-licenses complex generic drugs and biosimilars, serving regulated markets (US/EU), Latin America, and less regulated international markets through partner-based distribution.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Monoclonal Antibody (mAb) Biosimilars (HLAIAFAA)

akta.pro secondary industries

Erythropoietin (EPO) Biosimilars (HLAIAFAC), Growth Factor & Hematology Biosimilars (e.g., G-CSF, EPO) (HLAAAHAE), Oncology Biosimilars (HLAAAHAG)

Keywords

• Specialty pharmaceuticals
• Complex generic drugs
• Biosimilar development
• Out-licensing services
• Pharmaceutical contract development

Headquarters

HQ city

Falls Church

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Product Licensing and Out-licensing: The company specializes in development, manufacture, and out-licensing of specialty pharmaceutical products with emphasis on complex generic drug products and biologicals. Revenue generated through licensing arrangements with partners in regulated markets.
2. Biosimilar Product Sales: Sales of biosimilar products including EPO, filgrastim, insulin, and other biologicals to regulated and less regulated markets worldwide.
3. Generic Drug Products: Commercialization of generic drug products across various categories including transplant drugs, injectables, transdermals, oral CR/XR, complex IR products, inhalation products, and ophthalmic solutions.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels3 records

Core offering

Harvest Moon Pharmaceuticals develops, manufactures, and out-licenses specialty pharmaceutical products with emphasis on complex generic drug products and biosimilars. Its portfolio includes ANDA-stage generic drugs across therapeutic categories (transplant, injectables, transdermals, oral CR/XR, complex IR, inhalation, ophthalmic) and biosimilars (EPO, G-CSF, PEG filgrastim, beta interferon 1a/1b, insulin, insulin glargine, imiglucerase, enoxaparin, etanercept). It also offers contract technology services spanning proprietary high-yield cell lines, pedigreed cell lines, cDNA clones, expression cassettes, bioassays, purification processes, and analytical tools for biosimilar development.

Product overview

Harvest Moon Pharmaceuticals is a specialty pharmaceutical company that develops, manufactures, and out-licenses complex generic drug products and biologicals/biosimilars. The company operates a multi-faceted portfolio consisting of: (1) Generic Drug Products at ANDA stage and pipeline products across therapeutic areas including transplant drugs (cyclosporin, tacrolimus, rapamycin, everolimus), injectables (docetaxel, enoxaparin, zoledronic acid), transdermals, oral controlled-release formulations, complex IR products, inhalation products, and ophthalmic solutions; (2) Biosimilar Products including EPO, Neulasta (PEG filgrastim), Beta Interferon 1a and 1b, Insulin, Lantus (insulin glargine), Filgrastim G-CSF, Imiglucerase (Cerezyme), Enoxaparin, and Etanercept; and (3) Technology Services including high-performance stable cell lines, pedigreed cell lines for monoclonal antibodies (rituximab, bevacizumab, trastuzumab, infliximab, adalimumab, cetuximab), cDNA clones, proprietary expression cassettes, protein reference standards, purification processes, and analytical tools (bioassays, peptide mapping, glycan analysis). The company's manufacturing and development facilities have been approved by regulatory authorities from the US and EU.

Differentiator

Problem solved

Functional benefit

Products and services

• ANDA Stage Generic Drugs

Quantifiable outcome

• 30 generic drug products commercialized between 2002-2007
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Four partnerships are on record, tiered core and minor.

• TCI GenericscoreStrategic or Co-development Partner · 1 January 2007Harvest Moon Pharma was founded in 2007 and acquired TCI Generics' pipeline of 60+ products in varying states of development. TCI Generics had commercialized 30 generic drug products between 2002-2007 and had invested funds in development of 92 Complex Generic Drug products.
• PanGenerika B.V.coreChannel Partner/ Reseller/ DistributorPanGenerika B.V. provides Harvest Moon Pharma with access to an international marketing sales force. Located at Rijksstraatweg 426, 2243 CH Wassenaar, The Netherlands. This partnership enables the company to reach global markets for their specialty pharmaceutical products and biosimilars.
• Manufacturing Partners (China, Taiwan, Japan, Korea)coreOEM/ Whitelabel/ Licensing PartnerHarvest Moon Pharma upgrades finished dosage facilities of private/privatized companies in China, Taiwan, Japan, and Korea. These partnerships enable cost-effective manufacturing with facilities approved by US and EU regulatory authorities.
• EU cGMP Facility PartnersminorOEM/ Whitelabel/ Licensing PartnerMCB (Master Cell Bank) transferred to EU cGMP facility for scaling up Beta Interferon 1b and filing MAA via CP as EU biosimilar product.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Biocon: Indian biopharmaceutical company developing and commercializing biosimilars including trastuzumab, bevacizumab, insulin and G-CSF — directly overlapping with Harvest Moon's biosimilar targets across oncology, diabetes and hematology.
• Coherus Biosciences: US biosimilar developer focused on mAb and protein therapeutics including biosimilars to pegfilgrastim, ranibizumab and adalimumab. Comparable in being a development-stage biosimilar specialist targeting regulated markets.
• Samsung Bioepis: Biosimilar developer jointly backed by Samsung Biologics and Biogen, with approved biosimilars across etanercept, infliximab, adalimumab, trastuzumab and bevacizumab. Directly comparable in mAb biosimilar pipeline scope and partnership-based commercialization.
• Dr. Reddy's Laboratories: Indian generics and biosimilars developer with pipeline spanning rituximab, pegfilgrastim and other biosimilars as well as complex generics. Comparable mix of biosimilars and complex specialty generics with regulated-market ambitions.
• Aurobindo Pharma: Indian generic and biosimilar developer with a growing pipeline in biosimilars and complex injectables, leveraging low-cost manufacturing for global markets. Comparable in combining cost-efficient manufacturing with biosimilar and specialty generic pipeline.
• Apotex: Canadian generic pharmaceutical manufacturer with biosimilar development activities and complex generics portfolio. Comparable as a mid-sized private/closely-held specialty and biosimilar developer targeting North American and global regulated markets.
• Celltrion: Korean biosimilar developer and manufacturer, best known for infliximab biosimilar (Remsima/Inflectra) and trastuzumab biosimilar. Directly comparable to Harvest Moon on mAb biosimilar pipeline, manufacturing scale, and out-licensing GTM.

Broad incumbents

• Teva Pharmaceutical Industries: One of the largest global generics manufacturers with a growing biosimilars portfolio. Comparable as a broad incumbent spanning complex generics, biosimilars and specialty pharmaceuticals across regulated markets.
• Sandoz (Novartis): Global generics and biosimilars division of Novartis with one of the broadest biosimilar portfolios (rituximab, etanercept, infliximab, adalimumab, pegfilgrastim). Overlaps with Harvest Moon across virtually every biosimilar target.
• Mylan / Viatris: Global pharmaceutical company with significant biosimilars presence (including through the Biocon partnership) and large generic portfolio. Comparable breadth across complex generics and biosimilars for regulated markets.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/harvest-moon-pharmaceuticals

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 Harvest Moon Pharmaceuticals