Hikma 503B
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.
- Company typePrivate
- Founded-
- HeadquartersDayton, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Hikma 503B firmographics
Firmographics- 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
Hikma 503B industry classification
Industry- 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
Where Hikma 503B is headquartered
LocationHeadquarters
- HQ city
- Dayton
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Hikma 503B business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Operations, Personnel, Technology or R&D, Marketing or Sales
Revenue model
- 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
Hikma 503B product offering
Product offeringCore 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.
Companies that use Hikma 503B
Customer profileSegments2 records
Ideal customer profiles1 record
Hikma 503B technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Hikma 503B partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Inmar RX Solutions, Inc.minorInmar 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
Hikma 503B competitors and assessment
Company assessmentDirect 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
Hikma 503B social profiles
Digital presenceHikma 503B compliance and trust
Trust signalCompliance2 records
Hikma 503B financial estimates
Financial estimateRevenue estimate
Valuation estimate
Hikma 503B leadership team
Management profileNumber of profiles
Hikma 503B funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Hikma 503B M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Hikma 503B
What does Hikma 503B do?
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.
Is Hikma 503B a public or private company?
Hikma 503B is a private company. It is classified as corporate owned and is currently closed.
When was Hikma 503B founded?
Hikma 503B was founded in -1. It employs 11 to 50 people.
Where is Hikma 503B based?
Hikma 503B is headquartered in Dayton, United States, in the North America region.
How does Hikma 503B make money?
One revenue line is on record: compounded Sterile Preparations Sales.
Who are Hikma 503B's main competitors?
Direct peers on record are Wells Pharma of Houston, Leiters, Olympia Pharmaceuticals, Central Admixture Pharmacy Services (CAPS), QuVa Pharma and STAQ Pharma. Broad incumbents are Pfizer CentreOne, Baxter International, Pharmedium (Cencora) and Hikma Pharmaceuticals PLC.
Does Hikma 503B have an API?
No public API is recorded for Hikma 503B.
What industry is Hikma 503B in?
Hikma 503B's product category is Compounded Sterile Injectables. Its primary akta.pro industry code is HLAIABAL, Generic Hospital & Institutional Products, with a secondary code of HLAFALAL, 340B Program Administration & Contract Pharmacy Services. Its NAICS code is 325412 and its SIC code is 2834.