Pine Pharmaceuticals

What Pine Pharmaceuticals does

Pine Pharmaceuticals is an FDA-registered 503B outsourcing facility that compounds and repackages sterile pharmaceuticals for healthcare providers across the United States. Operating from a 75,000-square-foot cGMP-compliant facility in Tonawanda, New York, the company produces combination ophthalmic drops, intraocular injections, premix IV bags, topical ophthalmic solutions, repackaged bevacizumab in silicone-free pre-filled syringes, and specialty preparations such as calcium gluconate. Its portfolio spans 30+ products targeting hospitals, ambulatory surgery centers (ASCs), ophthalmology practices, otolaryngology (ENT) providers, and industrial manufacturers requiring chemical-exposure emergency preparedness products. Pine differentiates on regulatory compliance (USP <797>, USP <800>, ISO 5 cleanrooms with 24/7 environmental monitoring), 100% batch testing for potency, sterility, endotoxin, pH, and subvisible particulate matter, and extended dating up to 360 days on certain products. The company is independently owned by the Muto family (Alfonse Muto and Alfonse J. Muto, Pharm.D.), with roots in local compounding pharmacies dating to 1985 and formal incorporation as a 503B entity in 2014 following passage of Section 503B under the FD&C Act. Pine distributes "millions of units yearly" to thousands of facilities nationwide.

Pine generates revenue through direct B2B sales to enterprise healthcare buyers via a sales-led model with dedicated account managers, supplemented by an online customer portal (Pine Portal) offering autoship services for recurring orders with no shipping minimums. Products are sold at unit pricing via sales quotes or the portal, with active medical licenses required for certain controlled preparations. The go-to-market combines enterprise field sales targeting hospitals and surgery centers with event-driven lead generation at industry conferences (ASRS, ASCA, ASHP, AAO Annual Meeting, Compounding Pharmacy Compliance). Pine also offers custom development services for clinical trials and special projects, partnering with universities, governmental agencies, and healthcare companies. The MasterControl Quality Management System, Electronic Batch Records, and Logbook software underpin operational compliance, and Pine received MasterControl's 2023 Excellence in Analytics Award for quality-data utilization. The company has executed multiple facility expansions (5,000 sq ft in 2014, 25,000 sq ft in 2018, 50,000 sq ft in 2021-2022), assumed Athenex's 503B business in May 2023 (preserving 50+ jobs), and continues to expand its product catalog with launches across 2024 and 2025.

Name

Pine Pharmaceuticals

Legal name

Pine Pharmaceuticals LLC

Website

https://pinepharmaceuticals.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

101–250 employees

Short description

Pine Pharmaceuticals is an FDA-registered 503B outsourcing facility that compounds and repackages sterile pharmaceuticals — ophthalmic drops, intraocular injections, premix IV bags, and topical solutions — for hospitals, ambulatory surgery centers, ophthalmology practices, and specialty providers nationwide.

Ownership category

akta.pro rank

Headquarters

HQ city

Tonawanda

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Compounded Pharmaceutical Products: Sale of FDA-registered 503B outsourcing facility compounded and repackaged products including ophthalmic drops, intraocular injections, IV bags, and topical preparations. Products sold directly to hospitals, surgery centers, and specialty practices with ready-to-administer and extended dating benefits.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

Pine Pharmaceuticals operates an FDA-registered 503B outsourcing facility that manufactures and distributes sterile compounded and repackaged pharmaceutical products to hospitals, surgery centers, and specialty practices. The company produces ready-to-administer ophthalmic drops, intraocular injections, IV bags, topical ophthalmics, repackaged bevacizumab, and calcium gluconate preparations from a cGMP-compliant, ISO 5-certified 75,000 sq ft facility in Tonawanda, NY.

Product overview

Pine Pharmaceuticals is an FDA-registered 503B outsourcing facility offering a portfolio of high-quality compounded and repackaged pharmaceutical products. The portfolio includes: Combination Ophthalmic Drops (ComplEYE Drops® MDB, TPC Drops, Tropi-Phen®); Intraocular Injections (Bup-Lido, Epi-Caine, Lido-Phen, Moxifloxacin, Vancomycin); IV Bags (Calcium Chloride, Diltiazem HCl, Epinephrine, Phenylephrine HCl, Vasopressin); Repackaged Bevacizumab (SJJ Small Volume Syringe); Topical Ophthalmics (Edetate Disodium, Lidocaine HCl, Povidone-Iodine); and Additional Preparations (Calcium Gluconate in various forms, Dexamethasone Phosphate, Foscarnet Sodium, Lido-Oxy). The company also offers Custom Development Services for clinical trials and special projects. Products are manufactured in a cGMP-compliant 75,000-square-foot facility in Tonawanda, NY, with customer ordering managed through the Pine Portal.

Differentiator

Problem solved

Functional benefit

Brands

• Tropi-Phen: Combination ophthalmic drop containing Tropicamide 1% and Phenylephrine HCl 2.5%
• TPC Drops
• ComplEYE Drops
• Bup-Lido
• Epi-Caine
• Lido-Phen
• Lido-Oxy
• SJJ Small Volume Syringe

Products and services

• ComplEYE Drops® MDB Combination ophthalmic drop containing Moxifloxacin 0.5%-Dexamethasone 0.1%-Bromfenac 0.035% in a 5 mL multi-use dropper with a 180-day beyond-use date (BUD), used by ophthalmology practices and surgery centers for post-procedure treatment.
• TPC Drops Combination ophthalmic drop containing Tropicamide 1%-Phenylephrine HCl 2.5%-Cyclopentolate HCl 1% in a 5 mL multi-use dropper with a 150-day BUD, used for diagnostic mydriasis in ophthalmology and ASC settings.
• Tropi-Phen® 15 mL Combination ophthalmic drop containing Tropicamide 1%-Phenylephrine HCl 2.5% in a 15 mL multi-use dropper with a 180-day BUD, used for mydriasis in ophthalmic procedures.
• Tropi-Phen® 5 mL Combination ophthalmic drop containing Tropicamide 1%-Phenylephrine HCl 2.5% in a 5 mL multi-use dropper with a 180-day BUD, used for mydriasis in ophthalmic procedures.
• Bup-Lido Intraocular injection containing Bupivacaine HCl 0.375%-Lidocaine HCl 2% in a 5 mL pre-filled syringe for room-temperature storage with a 180-day BUD, used in ophthalmic surgical anesthesia.
• Epi-Caine Intraocular injection containing Epinephrine 0.025%-Lidocaine HCl 0.75% in a 1 mL single-use vial with frozen storage and a 150-day BUD, used in ophthalmic surgical procedures.
• Lido-Phen Intraocular injection containing Lidocaine HCl 1%-Phenylephrine HCl 1.5% in a 1 mL single-use vial with room-temperature storage and a 180-day BUD, used for ophthalmic procedures.
• Moxifloxacin 0.5 mg/0.5 mL Intraocular injection antibiotic in 0.5 mg/0.5 mL single-use vial with room-temperature storage and a 210-day BUD, used in ophthalmic surgery for endophthalmitis prophylaxis.
• Moxifloxacin 0.75 mg/0.5 mL Intraocular injection antibiotic in 0.75 mg/0.5 mL single-use vial with room-temperature storage and a 210-day BUD, used in ophthalmic surgery for endophthalmitis prophylaxis.
• Vancomycin Intraocular injection antibiotic in 1 mg/0.1 mL single-use vial with frozen storage and a 120-day BUD, used in ophthalmic surgical procedures.
• Calcium Chloride 10 g/500 mL IV bag containing Calcium Chloride 10 g per 500 mL with room-temperature storage and a 180-day BUD, used for hospital critical care pharmacy needs.
• Diltiazem HCl 125 mg/125 mL IV bag containing Diltiazem HCl 125 mg in 125 mL with room-temperature storage and a 150-day BUD, used in hospital critical care settings for rate control.
• Epinephrine 6 mg/250 mL IV bag containing Epinephrine 6 mg in 250 mL with room-temperature storage and a 180-day BUD, offered only while in shortage, used in hospital critical care.
• Phenylephrine HCl 25 mg/250 mL IV bag containing Phenylephrine HCl 25 mg in 250 mL with room-temperature storage and a 180-day BUD, used in hospital critical care settings.
• Phenylephrine HCl 40 mg/250 mL IV bag containing Phenylephrine HCl 40 mg in 250 mL with room-temperature storage and a 180-day BUD, used in hospital critical care settings.
• Phenylephrine HCl 50 mg/250 mL IV bag containing Phenylephrine HCl 50 mg in 250 mL with room-temperature storage and a 180-day BUD, used in hospital critical care settings.
• Vasopressin 20 units/100 mL IV bag containing Vasopressin 20 units in 100 mL with room-temperature storage and a 180-day BUD, used in hospital critical care settings.
• Vasopressin 40 units/100 mL IV bag containing Vasopressin 40 units in 100 mL with room-temperature storage and a 180-day BUD, used in hospital critical care settings.
• SJJ Small Volume Syringe Repackaged Bevacizumab 1.25 mg/0.05 mL in a silicone-free pre-filled syringe, FDA 510(k)-cleared, with refrigerated storage and a 180-day BUD, used in ophthalmology intravitreal injections.
• Edetate Disodium 1.5% Topical ophthalmic solution in 1 mL single-use vial with room-temperature storage and a 180-day BUD, used in ophthalmic procedures for calcium chelation.
• Lidocaine HCl 4% Topical ophthalmic solution in 3 mL single-use dropper with room-temperature storage and a 180-day BUD, used for ophthalmic surface anesthesia.
• Povidone-Iodine 5% Topical ophthalmic solution in 5 mL multi-use dropper with room-temperature storage and a 180-day BUD, used for ophthalmic pre-surgical antisepsis.
• Calcium Gluconate Inhalation Solution 2.5% Calcium Gluconate inhalation solution 2.5% in 5 mL pre-filled syringe with room-temperature storage and a 180-day BUD, used for hydrofluoric acid exposure treatment; requires active medical license for purchase.
• Calcium Gluconate Sterile Solution 1% Calcium Gluconate sterile solution 1% in 500 mL IV bag for ophthalmic irrigation with room-temperature storage and a 180-day BUD; requires active medical license for purchase.
• Calcium Gluconate Topical Gel 2.5% Calcium Gluconate topical gel 2.5% in 60 g jar with room-temperature storage and a 350-day BUD, used for hydrofluoric acid burn treatment; requires active medical license for purchase.
• Dexamethasone Phosphate 24 mg/mL Anti-inflammatory injection in 1 mL single-use vial with room-temperature storage and a 180-day BUD, used in ENT and ophthalmic procedures.
• Foscarnet Sodium 2.4 mg/0.1 mL Antiviral injection in 0.5 mL single-use vial, preservative free, with room-temperature storage and a 360-day BUD, used in ophthalmic viral infection treatment.
• Lido-Oxy Combination injection containing Lidocaine HCl 2%-Oxymetazoline HCl 0.025% in 2 mL pre-filled syringe with room-temperature storage and a 180-day BUD, used in ENT procedures.
• Custom Development Services Custom compounded solutions development for clinical trials and special projects, partnering with publicly and privately funded research organizations including universities, governmental agencies, and healthcare companies.

Quantifiable outcome

• 100% batch testing of all compounded units including visual inspection, sterility, potency, endotoxin, and particulate testing
• +2 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles5 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.

• MasterControlcoreTechnology or Integration · 1 January 2023MasterControl provides Quality Management System (QMS), Electronic Batch Records (EBR), and Logbook software integrated into Pine's operations. Pine was featured in a MasterControl case study and received the Excellence in Analytics award in 2023.

Scale indicators5 records

Recent moves13 records

Expansion highlights6 records

Direct peers

• QuVa Pharma: Largest US 503B outsourcing facility producing ready-to-administer sterile injectable and compounded preparations for hospitals and health systems — the closest direct competitor to Pine's 503B outsourcing model.
• Cantrell Drug Company: FDA-registered 503B outsourcing facility providing sterile compounded preparations (anesthetics, OR syringes, IV bags) to hospitals and surgery centers across the US, directly comparable in product mix and customer base to Pine.
• Olympia Pharmaceuticals: 503B-registered outsourcing facility producing sterile compounded pharmaceuticals including ophthalmics and injectables for hospitals and surgical centers, serving the same customer verticals as Pine.
• McGuff Compounding Pharmacy Services: FDA-registered 503B outsourcing facility specializing in sterile compounded preparations and repackaged injectables for hospitals, surgery centers, and clinics — overlapping product lines and customer segments with Pine.

Broad incumbents

• Central Admixture Pharmacy Services (CAPS) / B. Braun: B. Braun's CAPS network is one of the largest 503B outsourcing operations in the US, providing compounded sterile preparations and IV admixture services; broader portfolio and global backing give it scale advantages over Pine.
• PharMEDium Services (Cencora / AmerisourceBergen): Formerly one of the largest 503B compounders (now operating within Cencora/AmerisourceBergen); produces compounded sterile preparations for hospitals nationwide, comparable business model at significantly larger scale and with distribution synergies.
• Fagron: Global leader in pharmaceutical compounding with a broad portfolio of APIs, excipients, and personalized medicine services across multiple continents — comparable at the category level but far broader and more international than Pine.

Others

• Athenex: Parent entity whose 503B outsourcing business Pine acquired in May 2023 — directly relevant as the predecessor counterparty and source of product lines and customer relationships Pine absorbed.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/profile.php?id=100054570034155
• LinkedInlinkedin.com/company/5236517

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 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 Pine Pharmaceuticals