What Exela Pharma Sciences does

Exela Pharma Sciences, founded in 2005 and headquartered in Lenoir, North Carolina, is a US-based specialty pharmaceutical company that develops, manufactures, and markets proprietary and generic sterile injectable products and provides integrated contract development and manufacturing (CDMO) services to pharmaceutical innovators. The company operates two business units from a single 400,000+ square foot cGMP campus: a Finished Drug Products portfolio of more than 20 sterile injectables across ANDA, 505(b)(2) NDA, NDA, and 503B pathways (key brands include AKOVAZ, ELCYS, GLYRX-PF, NIPRIDE RTU, Bloxiverz, and Sodium Bicarbonate Injection) and a CDMO services division covering R&D, quality and regulatory, aseptic fill-finish (vials, IV bags, pre-filled syringes, lyophilization), and warehouse and logistics.

The technology base centers on cGMP sterile injectable manufacturing with isolator-based aseptic processing, high-speed automated vial and pre-filled syringe filling, DEA Schedule II-V controlled substance handling, terminal sterilization via high-capacity autoclaves, ultra-low-temperature biorepository storage, and integrated quality systems (LIMS, Empower chromatography, electronic quality system, ERP). The company has passed more than 15 FDA inspections since 2010 and is also approved by HealthCanada and the Australian TGA. Manufacturing capacity exceeds 100 million sterilized units per year, with disclosed excess capacity available for CDMO opportunities.

Exela generates revenue through two streams: sale of its own branded and generic injectable products to hospitals and health systems, and contract development and manufacturing services sold directly to pharmaceutical and biotech innovators. Products are distributed through Premier's group purchasing organization, Civica Rx (1,000+ hospital members), direct sales to health systems (including 11 health systems that are also minority investors in the parent holding company), and the company's own Exela Direct Store e-commerce platform. Pricing is negotiated through GPO contracts and direct quotes on multi-year terms; no public price list exists. The company has been subject to several voluntary recalls between 2022 and 2025 (particulate matter, vial breakage, and a Class I defective crimp recall), which represent an ongoing quality-execution consideration.

Name

Exela Pharma Sciences

Legal name

Exela Pharma Sciences, LLC

Website

https://exelapharma.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

251–500 employees

Short description

Exela Pharma Sciences is a US-based specialty pharmaceutical company founded in 2005 that develops and manufactures proprietary and generic sterile injectable products and provides integrated CDMO services from over 400,000 square feet of cGMP capacity in Lenoir, North Carolina, serving hospitals, health systems, and pharmaceutical innovators via Premier, Civica Rx, and direct channels.

Ownership category

akta.pro rank

Product category

Sterile Injectable Pharmaceuticals Manufacturing

NAICS

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

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

akta.pro secondary industries

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Sterile injectable manufacturing
• Pharmaceutical contract manufacturing
• Generic injectable products
• Aseptic fill-finish services
• CGMP pharmaceutical production

Headquarters

HQ city

Lenoir

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Proprietary and Generic Sterile Injectable Products: Exela manufactures and markets its own branded sterile injectable pharmaceutical products (ANDA, 505(b)(2) NDA, NDA, 503B) including sodium bicarbonate, caffeine citrate, ephedrine sulfate, glycopyrrolate, neostigmine, cysteine, and other injectables sold to healthcare providers and health systems.
2. CDMO Contract Development and Manufacturing Services: Exela provides contract development and manufacturing services to pharmaceutical companies, offering integrated drug formulation, analytical, aseptic fill-finish, lyophilization, and regulatory services from early-phase through commercialization.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

Exela Pharma Sciences develops, manufactures, and markets proprietary and generic sterile injectable pharmaceutical products in liquid vials, IV bags, lyophilized vials, and pre-filled syringes. The company also operates a CDMO business providing contract development, cGMP aseptic manufacturing, quality/regulatory, and warehouse/logistics services to pharmaceutical innovators from its Lenoir, North Carolina facilities.

Product overview

Exela Pharma Sciences operates two distinct business units: Finished Drug Products (proprietary and generic sterile injectables) and Contract Development and Manufacturing Organization (CDMO). The Finished Drug Products portfolio includes 20+ sterile injectable products marketed via ANDA, 505(b)(2) NDA, and 503b pathways. Key branded products include AKOVAZ (ephedrine sulfate), ELCYS (cysteine hydrochloride - only FDA approved cysteine injection), GLYRX-PF (glycopyrrolate), and NIPRIDE RTU (sodium nitroprusside). The CDMO services division provides end-to-end contract services including R&D (analytical, microbiology, formulation), cGMP manufacturing (vials, IV bags, prefilled syringes, lyophilization), quality/regulatory support, and warehouse/logistics from their Lenoir, NC facilities. The company manufactures liquid vials, lyophilized vials, IV bags, and pre-filled syringes.

Differentiator

Problem solved

Functional benefit

Products and services

• ELCYS (cysteine hydrochloride) Injection, USP 500 mg/10mL (50 mg/mL) single-dose vial of cysteine hydrochloride injection used as an additive to amino acid solutions for TPN; the only FDA-approved cysteine hydrochloride injection in the US market with aluminum content of no more than 120 parts per billion, addressing aluminum toxicity risk in parenteral nutrition patients.
• AKOVAZ (ephedrine sulfate) Injection Ephedrine sulfate injection available in 25 mg/5mL pre-filled syringe and 50 mg/mL single-dose vial presentations; a clear, colorless, sterile solution used for pressor support during anesthesia.
• Bloxiverz (Neostigmine Methylsulfate) Prefilled Syringe Pre-filled syringe of neostigmine methylsulfate injection USP for reversal of neuromuscular blockade following surgical procedures.
• GLYRX-PF (glycopyrrolate injection) Glycopyrrolate injection available in 1 mg/5mL pre-filled syringe, 0.2 mg/mL single-dose vial, and 0.4 mg/2mL single-dose vial presentations; used for anticholinergic indications including reduction of airway and gastric secretions during anesthesia.
• NIPRIDE RTU (sodium nitroprusside) Injection Ready-to-use sodium nitroprusside injection in 50 mg/100mL (0.5 mg/mL) and 20 mg/100mL (0.2 mg/mL) amber single-dose vials; sterile, unpreserved, colorless to red-brown solution for immediate blood pressure control.
• Sodium Bicarbonate Injection, USP Sodium bicarbonate injection in 4.2% (5 mEq/10mL) and 8.4% (50 mEq/50mL and 10 mEq/10mL) single-dose vial presentations; clear, sterile, nonpyrogenic, hypertonic solution for treatment of metabolic acidosis.
• Caffeine Citrate Injection and Oral Solution, USP Caffeine citrate 60 mg/3mL (20 mg/mL) injection vial and oral solution for treatment of neonatal apnea in premature infants.
• Tranexamic Acid Injection, IV Bag Tranexamic acid 1000 mg/100mL (10 mg/mL) single-dose polymeric IV bag for antifibrinolytic therapy to reduce or prevent hemorrhage.
• Potassium Acetate Injection, USP Potassium acetate injection USP in 40 mEq/20mL (2 mEq/mL) single-dose vials and 200 mEq/100mL (2 mEq/mL) pharmacy bulk vials for electrolyte replacement in IV admixtures.
• Verapamil Hydrochloride Injection, USP Verapamil hydrochloride injection USP 5 mg/2mL (2.5 mg/mL) single-dose vial for antiarrhythmic and cardiovascular use.
• Cupric Chloride Injection, USP Cupric chloride injection USP 4mg/10mL (0.4 mg/mL) single-dose plastic vial of sterile, nonpyrogenic solution for trace element supplementation in parenteral nutrition.
• Zinc Chloride Injection, USP Zinc chloride injection USP 10 mg/10mL (1 mg/mL) single-dose vial for trace element supplementation in parenteral nutrition.
• CDMO Research and Development Services Full-service R&D offering including small and large molecule capabilities, analytical services, microbiology labs, drug formulation development, and pre-formulation studies for parenteral, liquid, and lyophilized formulations; serves pharmaceutical and biotech innovators.
• CDMO cGMP Manufacturing Services cGMP parenteral drug product contract manufacturing including medium- and high-speed vial filling, IV bag filling, pre-filled syringe filling, lyophilization, aseptic and terminal sterilization, Schedule II-IV DEA controlled substance handling, stability programs, and automated inspection/labeling/packaging.
• CDMO Quality and Regulatory Services Quality and regulatory support with 15+ FDA inspections since 2010, experience with 505(b)(2) NDAs and ANDAs, regulatory filings for sterile injections, electronic quality systems, and pharmacovigilance for life science innovators.
• CDMO Warehouse and Logistics Services Warehousing, biorepository storage at ultra-low temperatures (-80°C to -70°C) and 2-8°C, temperature-controlled storage, global distribution, and cold chain capabilities for pharmaceutical and biotech customers.

Quantifiable outcome

• Over 100 million sterilized units per year manufacturing capacity with significant excess capacity for CDMO
• +3 more outcomes

Named customers13 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

One partnership is on record.

• Civica RxcoreChannel Partner/ Reseller/ Distributor · 11 September 2019Civica Rx, a non-profit organization formed in 2018 with mission to solve chronic drug shortages, signed a long-term agreement with Exela for distribution of Sodium Bicarbonate Injection to Civica's 1,000+ hospital members under the Civica label. Distribution began Q4 2019.

Scale indicators7 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Amphastar Pharmaceuticals: Amphastar is a US-based specialty pharmaceutical company focused on injectable, inhalation, and intranasal products, including generic sterile injectables sold to hospitals. It directly overlaps with Exela's proprietary/generic sterile injectable portfolio and its hospital-channel GTM motion.
• Fresenius Kabi: Fresenius Kabi is a global leader in sterile injectable generics, IV solutions, and parenteral nutrition, selling to hospitals and health systems worldwide. It competes head-to-head with Exela in generic sterile injectables (e.g., sodium bicarbonate) and large-volume parenterals sold through GPOs.
• Hikma Pharmaceuticals: Hikma is a multinational generic pharmaceutical manufacturer with a large US injectable portfolio sold to hospitals. It directly competes with Exela's branded and generic sterile injectable products through similar GPO and hospital channels.
• B. Braun Medical: B. Braun is a major manufacturer of sterile injectables, IV solutions, and parenteral nutrition products with significant US manufacturing capacity. It competes directly with Exela in the hospital sterile injectable space and also operates its own CDMO capabilities.
• Catalent: Catalent is a major global CDMO offering sterile fill-finish, prefilled syringe, and lyophilization services to pharma and biotech innovators. It competes with Exela's CDMO services for sterile injectable development and manufacturing contracts.
• Patheon (Thermo Fisher Scientific): Patheon, now part of Thermo Fisher's pharma services segment, is a leading global CDMO offering sterile injectable development, aseptic fill-finish, and commercial manufacturing. It directly competes with Exela's CDMO services for biotech and pharma customers.

Broad incumbents

• Pfizer Injectables (formerly Hospira): Pfizer's Injectables portfolio, inherited from Hospira, is the largest US hospital injectable franchise, offering a broad sterile injectable portfolio plus global CDMO services. It overlaps with Exela's portfolio and CDMO business as a much larger incumbent player.

Others

• Civica Rx: Civica is a non-profit hospital-owned drug manufacturer whose mission is to address chronic drug shortages through contracted manufacturing partnerships. Although not a direct competitor, it is a strategic partner/distributor for Exela and a channel for its shortage-list injectables.

Emerging players

• Kindeva Drug Delivery: Kindeva is a CDMO specializing in injectable, inhalation, and transdermal drug delivery, with US sterile manufacturing capacity. It competes with Exela for sterile injectable CDMO contracts and recently supplied Exela's new Chief Quality Officer.
• Aenova Group: Aenova is a European-headquartered CDMO offering sterile liquid and lyophilized injectable manufacturing, as well as oral solids. It competes with Exela for pharma innovator CDMO business, particularly for companies seeking transatlantic manufacturing options.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/exela-pharma-sciences-llc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds1 record

Investors11 records

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 Exela Pharma Sciences