Saptalis Pharmaceuticals

What Saptalis Pharmaceuticals does

Saptalis Pharmaceuticals, LLC is a privately held U.S.-based specialty pharmaceutical company founded in 2015 and headquartered in Hauppauge, New York. The company develops, manufactures, and commercializes complex generics and difficult-to-formulate dosage forms, with a focus on oral liquids (solutions, suspensions, nanosuspensions, microemulsions), topicals (creams, ointments, gels, sprays), and sterile ophthalmic and otic formulations. Saptalis holds 20+ FDA ANDA, sANDA, NDA, and sNDA approvals and operates from two cGMP-compliant facilities totaling 38,000 square feet with high-shear compounding, serialization, and unit dose packaging capabilities.

The company's business model combines three revenue streams. First, Saptalis sells approved generic and branded products directly to U.S. healthcare providers through an in-house sales and marketing team established in September 2023; flagship branded asset LIKMEZ is the first and only US FDA-approved ready-to-use oral suspension of metronidazole. Second, the company operates a CDMO service line offering formulation development, analytical and stability services, regulatory support, and commercial manufacturing for non-sterile and sterile liquid and semi-solid products. Third, Saptalis generates licensing and co-development revenue through partnerships, including a core agreement with Appili Therapeutics for ATI-1501 and strategic alliances with Taejoon, Micro Labs, Scigen, Solaris, and Scienture to bring 505(b)(2) and ANDA products to the U.S. market.

Saptalis serves primarily pediatric and geriatric patient populations who have difficulty swallowing solid dosage forms, alongside hospital-based care use cases requiring ready-to-use or sterile formulations. In June 2023, the company acquired 34 products from Akorn's Chapter 7 estate, materially expanding its commercial portfolio, and continues to build pipeline assets in CNS disorders and diabetes under the 505(b)(2) regulatory pathway. The company employs between 11 and 50 people and has raised approximately $9.5 million across two early-stage funding rounds in 2015 and 2016.

Name

Saptalis Pharmaceuticals

Legal name

Saptalis Pharmaceuticals, LLC

Website

https://saptalis.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Saptalis Pharmaceuticals is a privately held U.S. specialty pharmaceutical company that develops, manufactures, and commercializes complex generics and CDMO services in oral liquid, topical, and sterile ophthalmic/otic dosage forms, serving pediatric, geriatric, and hospital-based patient populations in the United States.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB)

akta.pro secondary industries

Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI), Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ)

Keywords

• Generic pharmaceuticals
• Specialty drug formulations
• CDMO services
• Oral liquid formulations
• Ophthalmic otic products

Headquarters

HQ city

Hauppauge

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, Supply Chain, Infrastructure, Marketing or Sales

Revenue model

1. Generic Pharmaceutical Products: Manufacturing and commercializing FDA-approved generic pharmaceutical products across multiple therapeutic categories including immunology, psychiatry, dermatology, neurology, ophthalmic, and infectious disease. Revenue generated through product sales to US customers via in-house sales team.
2. Branded Product Sales: Commercialization of proprietary branded products such as LIKMEZ (metronidazole oral suspension) under Saptalis label. LIKMEZ is the first and only US FDA-approved ready-to-use oral suspension of metronidazole.
3. CDMO Services: Contract development and manufacturing organization services including formulation development, analytical services, stability studies, regulatory support, and commercial manufacturing for non-sterile and sterile liquid and semi-solid pharmaceutical products.
4. Licensing & Co-Development: Revenue from licensing agreements and co-development partnerships for innovative 505(b)(2) and ANDA products. Includes partnership with Appili Therapeutics for manufacturing and commercialization of ATI-1501.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels3 records

Core offering

Saptalis Pharmaceuticals develops, manufactures, and commercializes complex generic and specialty prescription pharmaceutical products in niche therapeutic areas, with a specialized focus on difficult-to-formulate dosage forms including oral liquids, topicals, and sterile ophthalmic and otic formulations. The company also operates as a CDMO service provider, offering formulation development, analytical services, regulatory support, and commercial manufacturing to pharmaceutical partners, and licenses/co-develops products with strategic partners.

Product overview

Saptalis Pharmaceuticals is a specialty pharmaceutical company that develops, manufactures, and commercializes prescription products in niche therapeutic areas. The company offers a portfolio of branded and generic products across multiple therapeutic categories including Chronic Disease, Neurology, Dermatology, and Ophthalmic & Otic. Key branded products include LIKMEZ® (metronidazole) Oral Suspension. The company manufactures oral liquids, topicals, and sterile ophthalmic and otic formulations with U.S.-based cGMP facilities. Saptalis also provides CDMO (Contract Development and Manufacturing Organization) services including formulation development, analytical services, stability studies, regulatory support, and commercial manufacturing for non-sterile and sterile liquid and semi-solid pharmaceutical products.

Differentiator

Problem solved

Functional benefit

Brands

• LIKMEZ: Metronidazole Oral Suspension 500 mg/5mL (100mg/mL) - The First and Only US FDA-Approved Ready-Use Oral Suspension for patients with difficulty swallowing.

Products and services

• LIKMEZ (Metronidazole Oral Suspension) 500 mg/5mL The first and only US FDA-approved ready-to-use oral suspension of metronidazole (500 mg/5mL), an innovative liquid formulation developed specifically for patients with difficulty swallowing or taste sensitivities. Branded prescription product.
• Cyclosporine Ophthalmic Emulsion 0.05% Preservative-free treatment for dry eye disease available in 30- and 60-count single-use vials. Generic prescription product for ophthalmic use.
• Fluoxetine Oral Solution, USP 20 mg/5 mL Prescription-only selective serotonin reuptake inhibitor (SSRI) for the treatment of various psychiatric conditions. Generic oral solution formulation.
• Metronidazole Vaginal Gel, 0.75% FDA ANDA approved vaginal gel formulation of metronidazole for indicated uses. Generic prescription product.
• Glycopyrrolate Oral Solution, 1mg/5mL FDA ANDA approved oral solution formulation of glycopyrrolate. Generic prescription product.
• Lithium Oral Solution USP, 8 mEq/5 mL FDA ANDA approved oral solution formulation of lithium. Generic prescription product for psychiatric indications.
• Triamcinolone Acetonide Topical Cream 0.1% Topical corticosteroid cream formulation. FDA sANDA approved generic prescription product for dermatological indications.
• Triamcinolone Acetonide Topical Lotion 0.1% Topical corticosteroid lotion formulation. FDA sANDA approved generic prescription product.
• Erythromycin Topical Solution 2% Topical antibiotic solution formulation. FDA sANDA approved generic prescription product.
• Acetic Acid Otic Solution USP, 2% Otic solution formulation of acetic acid. FDA sANDA approved generic prescription product for ear-related indications.
• Metformin HCl Oral Solution, 500 mg/5mL FDA ANDA approved oral solution indicated as an adjunct to diet and exercise for type 2 diabetes. Generic prescription product.
• Levocarnitine Oral Solution, 1gm/10mL FDA ANDA approved oral solution formulation of levocarnitine. Generic prescription product.
• Potassium Chloride Oral Solution FDA ANDA approved oral solution in 20 MEQ/15mL and 40 MEQ/15mL strengths for treatment of patients with potassium deficiency. Generic prescription product.
• Hydrocortisone and Acetic Acid Otic Solution FDA sNDA approved otic solution formulation. Generic prescription product for ear-related indications.
• Clobetasol Propionate Topical Solution Topical corticosteroid formulation. FDA ANDA approved generic prescription product.
• CDMO Formulation Development Services Contract formulation development services for pharmaceutical partners, covering oral solutions, suspensions, ophthalmic emulsions, and topical products. Service offering targeted at pharmaceutical companies lacking in-house specialty formulation expertise.
• CDMO Analytical Services Contract analytical services including method development, validation, and release testing. Service offering targeted at pharmaceutical partners requiring analytical support.
• CDMO Stability Studies ICH-compliant stability studies conducted under various conditions including 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, 2–8°C, and photostability testing. Contract service offering.
• CDMO Regulatory Support Services Contract regulatory support services including PIND, IND, NDA, ANDA submissions and lifecycle management. Service offering for pharmaceutical partners seeking U.S. regulatory pathway expertise.
• CDMO Commercial Manufacturing Services Contract commercial manufacturing with serialization and unit dose packaging capabilities, utilizing high-shear compounding and packaging lines. Service offering for pharmaceutical partners requiring commercial-scale production.

Quantifiable outcome

• First and only US FDA-approved ready-to-use oral suspension of metronidazole (LIKMEZ)
• +2 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Appili Therapeutics Inc.coreStrategic or Co-development Partner · 19 December 2019Exclusive licensing agreement for manufacturing and commercialization of ATI-1501. Saptalis manufactures and commercializes Appili's products including LIKMEZ in the U.S. market. Saptalis serves as the manufacturing and commercialization partner while Appili focuses on drug development and pipeline advancement.
• Taejoon PharmaceuticalsminorStrategic or Co-development PartnerGlobal collaboration to bring high-value pharmaceutical products to the U.S. market through strategic alliance.
• Micro Labs LimitedminorStrategic or Co-development PartnerGlobal collaboration to bring high-value pharmaceutical products to the U.S. market through strategic alliance.
• Scigen PharmaminorStrategic or Co-development PartnerGlobal collaboration to bring high-value pharmaceutical products to the U.S. market through strategic alliance.
• Solaris PharmaminorStrategic or Co-development PartnerGlobal collaboration to bring high-value pharmaceutical products to the U.S. market through strategic alliance.
• ScientureminorStrategic or Co-development PartnerGlobal collaboration to bring high-value pharmaceutical products to the U.S. market through strategic alliance.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• ANI Pharmaceuticals: U.S. specialty generic and branded pharmaceutical company with significant CDMO capabilities. Highly comparable given ANI's focus on complex generics, niche therapeutic areas, and integrated manufacturing/services model.
• Padagis: Specialty generics business focused on niche topical, oral, and ophthalmic products. Highly comparable business model combining complex dosage expertise with selective branded specialty assets.
• Upsher-Smith Laboratories: U.S.-based specialty generics and branded pharmaceutical manufacturer with comparable therapeutic-area diversity and CDMO-adjacent capabilities.
• Somerset Therapeutics: Specialty generic pharmaceutical manufacturer focused on ophthalmology and complex injectable/sterile dosage forms. Closely aligned with Saptalis's emphasis on ophthalmic emulsions and complex formulations.
• Lannett Company: U.S. generic drug developer and manufacturer with broad solid oral, topical, and liquid portfolio. Comparable as a U.S.-focused generic pharmaceutical developer with diversified ANDA portfolio.

Broad incumbents

• Endo International: Diversified specialty pharmaceutical company with significant generic and sterile injectable capabilities, competing broadly with Saptalis across several generic therapeutic categories.
• Amneal Pharmaceuticals: Large U.S.-headquartered generic and specialty pharmaceutical manufacturer with significant generic injectables, oral, topical, and ophthalmic exposure—anchoring the same competitive set as Saptalis but at much greater scale.
• Taro Pharmaceutical Industries: Generic pharmaceutical manufacturer (Sun Pharma subsidiary) with strong U.S. topical, oral liquid, and dermatology presence—directly contesting several of Saptalis's therapeutic categories.

Regional players

• Alembic Pharmaceuticals: India-headquartered generic pharmaceutical manufacturer with U.S. ANDA filings and complex dosage expertise. Comparable in therapeutic-area breadth and generic portfolio approach.

Others

• Appili Therapeutics: Strategic partner of Saptalis for LIKMEZ commercialization and ATI-1501 development. Not a direct competitor but a key alliance partner and a relevant comparator in anti-infective specialty pharma.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds2 records

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 Saptalis Pharmaceuticals