Hikma 503B

What Hikma 503B does

Hikma 503B was the FDA-registered 503B outsourcing facility division of Hikma Injectables USA Inc., a subsidiary of Hikma Pharmaceuticals PLC. It produced high-quality, ready-to-administer compounded sterile injectable medications customized to hospital and patient needs, serving US hospitals and hospital pharmacy teams. The portfolio comprised 17 sterile injectable products spanning benzodiazepines (e.g., midazolam, lorazepam, diazepam), opioid analgesics (fentanyl, hydromorphone, remifentanil), anesthetic agents (propofol, etomidate, ketamine), neuromuscular blocking agents (rocuronium, succinylcholine, cisatracurium, vecuronium), and barbiturates (pentobarbital, phenobarbital).

The business operated from a dedicated, purpose-built facility designed to meet FDA 503B outsourcing requirements, with cGMP-compliant sterile manufacturing processes. Every batch was tested for sterility, potency, and endotoxins. Hikma 503B leveraged parent-group scale — including supplier relationships spanning more than 120 drug products and the manufacture of hundreds of millions of vials for US hospitals — to ensure raw material access and supply continuity. Distribution was direct to hospitals via a dedicated field sales team, customer service operations (888-203-5862), and the proprietary hikmadirect.com online ordering platform.

The 503B division's commercial model was B2B enterprise sales to US hospitals with quote-based procurement pricing; no public pricing was disclosed. Hikma 503B has since permanently ceased operations, with the website explicitly stating the company is closed and redirecting customers to Hikma.com for the broader sterile injectable portfolio.

Name

Hikma 503B

Legal name

Hikma Injectables USA Inc.

Website

https://hikma503b.com

Company type

Private

Operating status

Closed

Headcount range

11–50 employees

Short description

Hikma 503B was Hikma Pharmaceuticals' FDA-registered 503B outsourcing facility producing ready-to-administer compounded sterile injectable medications for US hospitals and pharmacy teams. The division is now permanently closed.

Ownership category

akta.pro rank

Product category

Compounded Sterile Injectables

NAICS

Pharmaceutical Preparation Manufacturing (325412), Drugs and Druggists' Sundries Merchant Wholesalers (42421)

SIC

Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Generic Hospital & Institutional Products (HLAIABAL)

akta.pro secondary industry

340B Program Administration & Contract Pharmacy Services (HLAFALAL)

Keywords

• Compounded sterile preparations
• 503B outsourcing facility
• Sterile injectable medications
• Hospital pharmacy supply
• CGMP pharmaceutical manufacturing

Headquarters

HQ city

Dayton

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Compounded Sterile Preparations Sales: Sale of high-quality compounded sterile injectable medications to US hospitals. Products include ready-to-administer injectable medications customized to specific patient needs.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Hikma 503B was an FDA-Registered 503B Outsourcing Facility that manufactured and sold high-quality, ready-to-administer compounded sterile injectable medications to US hospitals under cGMP standards. The portfolio comprised 17 distinct sterile injectable products spanning benzodiazepines, opioid analgesics, anesthetic agents, neuromuscular blocking agents, and barbiturates, supplied via the HikmaDirect.com ordering platform and direct enterprise sales. The company has since been permanently closed, with continued sterile injectable supply now handled through Hikma's broader portfolio.

Product overview

Hikma 503B is an FDA-Registered 503B Outsourcing Facility providing high-quality, ready-to-administer compounded sterile injectable medications customized for hospital and patient needs. The portfolio consists of 17 distinct sterile injectable products including benzodiazepines (ATIVAN, DIAZEPAM, LORAZEPAM, MIDAZOLAM), opioid analgesics (FENTANYL, HYDROMORPHONE, REMIFENTANIL), anesthetic agents (ETOMIDATE, KETAMINE, PROPOFOL), neuromuscular blocking agents (CISATRACURIUM, ROCURONIUM, SUCCINYLCHOLINE, VECURONIUM), and barbiturates (PENTOBARBITAL, PHENOBARBITAL). The company operates under cGMP standards and provides these products to US hospitals as a reliable source of compounded sterile preparations (CSPs).

Differentiator

Problem solved

Functional benefit

Products and services

• ATIVAN INJECTION Benzodiazepine injection used for sedation, anesthesia induction, and management of status epilepticus, supplied to US hospitals as a compounded sterile injectable.
• CISATRACURIUM BESYLATE INJECTION Neuromuscular blocking agent used for endotracheal intubation and to provide skeletal muscle relaxation during surgery, supplied to US hospitals as a compounded sterile injectable.
• DIAZEPAM INJECTION Benzodiazepine injection used for sedation, anxiety relief, muscle spasm relief, and seizure management, supplied to US hospitals as a compounded sterile injectable.
• ETOMIDATE INJECTION Intravenous anesthetic agent used for induction of general anesthesia, supplied to US hospitals as a compounded sterile injectable.
• FENTANYL CITRATE INJECTION Opioid analgesic used for anesthesia, analgesia, and sedation in hospital settings, supplied to US hospitals as a compounded sterile injectable.
• HYDROMORPHONE HCL INJECTION Potent opioid analgesic used for management of severe pain in hospital settings, supplied to US hospitals as a compounded sterile injectable.
• KETAMINE HCL INJECTION Dissociative anesthetic used for induction and maintenance of anesthesia and pain management, supplied to US hospitals as a compounded sterile injectable.
• LORAZEPAM INJECTION Benzodiazepine injection used for sedation, anxiety management, and seizure control, supplied to US hospitals as a compounded sterile injectable.
• MIDAZOLAM HCL INJECTION Short-acting benzodiazepine used for sedation, anxiolysis, and amnesia prior to procedures, supplied to US hospitals as a compounded sterile injectable.
• MIDAZOLAM SODIUM CHLORIDE INJECTION Midazolam in sodium chloride solution for intravenous sedation and anesthesia induction, supplied to US hospitals as a compounded sterile injectable.
• PENTOBARBITAL SODIUM INJECTION Barbiturate used for sedation, anesthesia, and treatment of seizures, supplied to US hospitals as a compounded sterile injectable.
• PHENOBARBITAL SODIUM INJECTION Barbiturate used for seizure control, sedation, and long-term management of seizure disorders, supplied to US hospitals as a compounded sterile injectable.
• PROPOFOL INJECTION EMULSION Intravenous sedative-hypnotic agent used for induction and maintenance of anesthesia and sedation, supplied to US hospitals as a compounded sterile injectable.
• REMIFENTANIL HCL INJECTION Potent opioid analgesic with rapid offset used for perioperative analgesia and anesthesia, supplied to US hospitals as a compounded sterile injectable.
• ROCURONIUM BROMIDE INJECTION Neuromuscular blocking agent used for rapid sequence intubation and surgical relaxation, supplied to US hospitals as a compounded sterile injectable.
• SUCCINYLCHOLINE CHLORIDE INJECTION Depolarizing neuromuscular blocker used for rapid sequence intubation and short surgical procedures, supplied to US hospitals as a compounded sterile injectable.
• VECURONIUM BROMIDE INJECTION Non-depolarizing neuromuscular blocking agent used for surgical muscle relaxation, supplied to US hospitals as a compounded sterile injectable.

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Inmar RX Solutions, Inc.minorImplementation/ SI/ Consulting PartnerInmar RX Solutions, Inc. serves as Hikma 503B's designated return processing agent for product returns. Returns must be shipped to Inmar RX Solutions, Inc. at 3845 Grand Lakes Way, Suite 125, Grand Prairie, TX 75050. Inmar validates returned products and Hikma issues credit based on Inmar's validation.

Scale indicators2 records

Recent moves3 records

Direct peers

• Wells Pharma of Houston: Wells Pharma of Houston operates as an FDA-registered 503B outsourcing facility producing sterile injectable preparations for US hospitals, directly comparable to Hikma 503B in regulatory standing and product focus.
• Leiters: Leiters is an FDA-registered 503B outsourcing facility specializing in sterile injectable preparations for hospital and outpatient settings, directly comparable to Hikma 503B in business model and customer base.
• Olympia Pharmaceuticals: Olympia Pharmaceuticals operates an FDA-registered 503B outsourcing facility providing compounded sterile preparations to hospital and clinic customers, directly comparable to Hikma 503B in operational model and target market.
• Central Admixture Pharmacy Services (CAPS): CAPS, part of B. Braun, is a major FDA-registered 503B outsourcing facility providing compounded sterile preparations and admixture services to hospitals nationwide, directly competing with Hikma 503B in the same outsourced compounding space.
• QuVa Pharma: QuVa Pharma is a leading FDA-registered 503B outsourcing facility producing compounded sterile preparations for US hospitals, directly competing with Hikma 503B in the same ready-to-administer injectable market.
• STAQ Pharma: STAQ Pharma operates as an FDA-registered 503B outsourcing facility producing compounded sterile preparations for hospitals, with a similar product portfolio of ready-to-administer injectables serving identical hospital pharmacy customers.

Broad incumbents

• Pfizer CentreOne: Pfizer CentreOne is Pfizer's contract manufacturing and 503B outsourcing services arm, competing with Hikma 503B in sterile injectable manufacturing for hospital customers but operating at significantly larger scale within a major pharmaceutical company.
• Baxter International: Baxter International is a major manufacturer and compounder of sterile injectable medications and IV solutions for US hospitals, with portfolio overlap and customer overlap with Hikma 503B but at substantially broader scale across multiple product categories.
• Pharmedium (Cencora): Pharmedium, now part of Cencora (formerly AmerisourceBergen), is a long-established 503B outsourcing facility serving hospitals at scale, competing with Hikma 503B but operating as part of a much larger pharmaceutical distribution platform.
• Hikma Pharmaceuticals PLC: Hikma Pharmaceuticals PLC is the parent company of Hikma 503B and a leading global supplier of generic injectable medicines to US hospitals; the broader sterile injectables franchise continues to compete in the same hospital market as the closed 503B unit.

Market position

Strengths3 records

Weaknesses3 records

Competitive moat4 records

Key risks5 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/hikma-503b

Compliance2 records

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 Hikma 503B