Sterling Pharmaceutical Services

What Sterling Pharmaceutical Services does

Sterling Pharmaceutical Services LLC is a privately held, family-owned contract development and manufacturing organization (CDMO) founded in 2005 by Robert G. Flynn and Robert T. Flynn, headquartered in a single centralized facility in Dupo, Illinois. The company provides end-to-end pharmaceutical services — from pre-formulation and analytical development through commercial manufacturing, packaging, stability, and regulatory support — under DEA (C2-C5), FDA, and cGMP certifications. Its manufacturing footprint spans sterile ophthalmic (solutions, suspensions, ointments, gels, aseptic fills), topical (liquid and semi-solid in batches up to 1,000 kg), solid dose (over 750 million tablets annually, 25-300 kg batch sizes), and high-potency compound handling with closed containment. Sterling serves five market verticals — ophthalmic (its specialty), prescription drugs, over-the-counter products, veterinary medications, and homeopathic remedies — and claims to have guided more than 400 products to market across NDA, ANDA, 505(b)(2), OTC, and nutritional supplement pathways.

The underlying technology is grounded in conventional, validated pharmaceutical chemistry rather than novel platforms: analytical instrumentation includes HPLC, GC, IR, dissolution, Karl Fischer water determination, and USP-compliant microbiological methods (USP 51, 60-62, 71, 787-789), supported by stability chambers from -80°C to 40°C/75% RH and ICH Q1b photo-stability capability. Forensic deformulation is offered to support FDA Biowaiver (Q1/Q2 match) exemptions, an uncommon capability that differentiates Sterling from generalist CMOs.

Sterling monetizes services through project-based and per-batch contract manufacturing fees negotiated directly with clients via its website inquiry form, phone outreach, and industry association channels (AAPS, APhA, CRS, ISPE, NSF). Pricing is not publicly disclosed and is typically structured around multi-year development and manufacturing engagements. The go-to-market motion is enterprise-focused, selling to pharmaceutical and biotech companies requiring cGMP manufacturing — including a recently announced clinical-supply agreement with Curative Biotechnology for ophthalmic clinical trial material. The company operates exclusively on a domestic, single-site B2B model with no retail, distribution, or international expansion disclosed in the source data.

Name

Sterling Pharmaceutical Services

Legal name

Sterling Pharmaceutical Services LLC

Website

https://sterlingpharma.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

51–100 employees

Short description

Sterling Pharmaceutical Services is a privately held U.S. CDMO providing formulation development, cGMP contract manufacturing, and analytical testing across sterile ophthalmic, topical, solid dose, and high-potency dosage forms for pharma, biotech, and OTC clients.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing (CDMO)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

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

akta.pro secondary industries

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD), Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM)

Keywords

• Pharmaceutical contract manufacturing
• Contract development services
• Pharmaceutical formulation development
• CGMP sterile manufacturing
• Drug release testing

Headquarters

HQ city

Dupo

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Development and Manufacturing (CDMO) Services: Sterling Pharmaceutical Services operates as a contract development and manufacturing organization (CDMO), generating revenue through formulation development, clinical and commercial manufacturing, analytical testing, and regulatory support services for pharmaceutical clients. Revenue is earned through project-based fees for development services and per-batch manufacturing fees for production runs, serving NDA, ANDA, 505(b)(2), OTC, and nutritional supplement clients.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Sterling Pharmaceutical Services is a U.S.-based pharmaceutical Contract Development and Manufacturing Organization (CDMO) that provides end-to-end services from concept to commercialization. The company offers formulation development, cGMP commercial manufacturing (sterile ophthalmic, topical, solid dose, high potent compounds), analytical and microbiological testing, stability storage, and regulatory filing support across NDA, ANDA, 505(b)(2), OTC, veterinary, homeopathic, and nutritional supplement products within a single DEA (C2-C5) and FDA-certified facility.

Product overview

Sterling Pharmaceutical Services is a U.S.-based Contract Development and Manufacturing Organization (CDMO) providing end-to-end pharmaceutical services from concept to commercialization. The company operates DEA (C2-C5) and FDA certified facilities with cGMP compliance, offering integrated R&D Services (formulation development, pre-formulation), Manufacturing Services (sterile ophthalmic, topical, solid dose, high potent compounds), Analytical Services, Drug Release Testing, Microbiological Services, and Stability Testing & Storage. The company serves specialized market verticals including Ophthalmic Products (their specialty), Rx/Prescription drugs, OTC medications, Veterinary pharmaceuticals, and Homeopathic remedies. With capacity to handle over 400 products into market including NDAs, ANDAs, OTC, and nutritional supplements, Sterling provides technology transfer services for ANDA/NDA transfers and has annual solid dose capacity exceeding 750 million tablets.

Differentiator

Problem solved

Functional benefit

Products and services

• R&D Services (Research & Development) Comprehensive formulation development services including pre-formulation studies, design of experiments, tablet & capsule development, product re-formulation, scale-up, site transfer, SUPAC guidance, and packaging & distribution — for pharmaceutical clients bringing products from concept to commercialization.
• Manufacturing Services cGMP-compliant pharmaceutical contract manufacturing covering sterile ophthalmic (solutions, suspensions, ointments, gels), topical formulations (liquid and semi-solid up to 1,000 kg batches), solid dose tablets (annual capacity exceeding 750 million tablets, batch sizes 25-300 kg), high potent compounds with closed-system containment, and technology transfer for ANDA/NDA submissions.
• Analytical Services Analytical method development, forensic de-formulation, compatibility studies, method optimization, product analysis, and stability-indicating assays using HPLC, GC, IR, dissolution, and Karl Fischer instrumentation — supporting NDA and ANDA regulatory submissions.
• Drug Release Testing Drug dissolution and release testing utilizing HPLC, GC, IR, Dissolution, and Karl Fischer Water Determination for finished product quality control release testing, method development/validation, and extractable/leachable testing.
• Microbiological Services USP/NF-compliant microbiology testing including microbial limit tests (USP 60, 61, 62), sterility testing (USP 71), particulate matter testing (USP 787, 788, 789), antimicrobial effectiveness testing (USP 51), bioburden testing, water testing, and clean room/controlled environment monitoring.
• Stability Testing & Storage Stability testing and storage supporting short- and long-term pharmaceutical programs with monitored chambers ranging from -80°C to 40°C/75% RH, including photo-stability per ICH Q1b, continuous monitoring, emergency power systems, and shelf-life determination following ICH guidelines.
• Ophthalmic Products Manufacturing Sterile ophthalmic contract manufacturing including solutions, suspensions, ointments, gels, antibiotic and lubricant ointments, diagnostic solutions, and full deformulation services for Biowaiver (Q1/Q2 match) FDA filings — Sterling's specialty market vertical.
• Rx (Prescription) Drug Manufacturing Prescription drug formulation, development, and contract manufacturing for IND, NDA, ANDA, and 505(b)(2) applications including solubility/bioavailability enhancement, modified/controlled release, sprinkle format, mini tablets, ODTs, and suspension solutions.
• OTC (Over-the-Counter) Drug Manufacturing Over-the-counter tablet and liquid product manufacturing for antacids, NSAIDs, cough/cold tablets and liquids, mouthwashes, dermatological creams, ophthalmic solutions and ointments, and antihistamines.
• Veterinary Pharmaceutical Manufacturing Veterinary medication manufacturing for companion animal, equine, and bovine markets including osteoarthritis and antihistamine formulations; dose formats include chewable flavored tablets, chewable controlled release tablets, sprinkle formats, and fast dissolving tablets.
• Homeopathic Pharmaceutical Manufacturing Homeopathic remedy manufacturing approved by the Homeopathic Pharmacopeia of the United States (HPUS) in tablet, capsule, solution, and powder solution formulations compliant with FDA guidelines and the Food, Drug, and Cosmetic Act.

Quantifiable outcome

• Over 400 products guided into the market including NDAs, ANDAs, OTC products, and Nutritional Supplements
• +2 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature11 records

Partnerships

Six partnerships are on record, tiered minor and core.

• American Association of Pharmaceutical Scientists (AAPS)minorOthersSterling Pharmaceutical Services is a member of AAPS, an industry association that connects pharmaceutical scientists and provides professional development, networking, and standards-setting across the pharmaceutical industry.
• American Pharmacists Association (APhA)minorOthersSterling Pharmaceutical Services holds membership in the American Pharmacists Association, supporting professional engagement and industry advocacy within the U.S. pharmacy and pharmaceutical community.
• Controlled Release Society (CRS)minorOthersSterling Pharmaceutical Services is a member of the Controlled Release Society, an international organization focused on delivery science and technology, aligning with Sterling's formulation and drug delivery capabilities.
• International Society for Pharmaceutical Engineering (ISPE)minorOthersSterling Pharmaceutical Services is a member of ISPE, a global organization providing best practices, regulatory guidance, and professional development for pharmaceutical engineering and manufacturing professionals.
• National Sanitation Foundation (NSF)minorOthersSterling Pharmaceutical Services is a member of NSF International, which provides public health and safety risk management solutions including testing, certification, and standards development for consumer products and pharmaceuticals.
• Curative BiotechnologycoreStrategic or Co-development PartnerCurative Biotechnology engaged Sterling Pharmaceutical Services to manufacture clinical supply of its metformin-based topical ophthalmic formulation for degenerative eye diseases. The manufacturing agreement supports a planned first-in-human Phase 1 clinical study in dry Age-Related Macular Degeneration and a K9 clinical study targeting PDE6-associated retinal degeneration, advancing Curative's metformin-based ophthalmology platform toward clinical evaluation under its existing license from the National Eye Institute.

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Pillar5 Pharma: Canadian CDMO specializing in sterile ophthalmic, otic, and small-molecule drug product manufacturing. Most direct overlap with Sterling on sterile ophthalmic capabilities and DEA-registered handling.
• Alcami: U.S.-based CDMO offering small-molecule formulation, analytical development, sterile and oral solid dose manufacturing. Closely comparable to Sterling on scope, geography, and target customer (small-to-mid biotech and specialty pharma).
• Pharmaceutics International Inc (Pii): U.S.-based CDMO providing formulation development, analytical services, and cGMP manufacturing for sterile, solid dose, and specialty dosage forms. Comparable mid-sized peer with similar service breadth and customer mix.
• Halo Pharma: U.S. CDMO offering solid dose, sterile, and semi-solid manufacturing for small-molecule drug products. Comparable in scale, customer base (small-to-mid pharma), and regulatory positioning to Sterling.
• Woodstock Sterile Solutions: U.S. CDMO focused on sterile injectable and ophthalmic manufacturing including aseptic fill-finish. Directly comparable on sterile ophthalmic niche that Sterling identifies as its specialty.

Broad incumbents

• Catalent: Global leader in small-molecule and biologic CDMO services including oral solid dose, sterile fill-finish, and ophthalmic manufacturing. Directly comparable as Sterling's largest scaled competitor for small-molecule drug product CDMO work.
• Aenova: European-headquartered CDMO with broad solid dose, semi-solid, and sterile manufacturing capabilities. Comparable on dosage form breadth though Sterling is more ophthalmic-focused and Aenova is larger and more diversified geographically.
• Recipharm: Global CDMO providing small-molecule development, manufacturing, and analytical services across multiple dosage forms. Comparable in offering though larger and more geographically diversified than Sterling.

Others

• Cambrex: Established mid-size CDMO providing small-molecule API and drug product development/manufacturing services. Comparable on small-molecule drug product offering with broader API capabilities Sterling does not emphasize.

Emerging players

• Ascendia Pharmaceuticals: Smaller specialty CDMO providing formulation development and small-batch sterile, semi-solid, and oral manufacturing for early-stage pharma. Comparable to Sterling on dosage form coverage and customer segment (small/specialty pharma) but smaller in scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/Sterling-Pharmaceutical-Services-790823270976270

Compliance14 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Sterling Pharmaceutical Services