epinephrine; lidocaine hydrochloride: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun Medical	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	208475	ANDA	B. Braun Medical Inc.	0264-9378-05	5 AMPULE in 1 CARTON (0264-9378-05) / 5 mL in 1 AMPULE (0264-9378-88)	2021-09-08
Hospira	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	089635	ANDA	Henry Schein, Inc.	0404-9886-50	1 VIAL, MULTI-DOSE in 1 BAG (0404-9886-50) / 50 mL in 1 VIAL, MULTI-DOSE	2022-01-11
Hospira	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	089635	ANDA	Hospira, Inc.	0409-3177-01	25 VIAL, MULTI-DOSE in 1 TRAY (0409-3177-01) / 50 mL in 1 VIAL, MULTI-DOSE (0409-3177-16)	2005-11-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 25, 2026

Suppliers for Epinephrine and Lidocaine Hydrochloride (API, USP/EP, and Injection-Grade)

Epinephrine and lidocaine hydrochloride are widely supplied as branded and generic APIs and as ready-to-use sterile injectables. Supply risk is mostly driven by (1) sterile manufacturing and extractables/leachables control for injectables, (2) regulatory status of the specific grade (USP, EP, Ph. Eur., with specified polymorph/assay limits where applicable), and (3) export/import licensing and GMP inspection history for the originating sites.

Core takeaway: Supplier selection should be split by product form: API sourcing (multiple Asian and European API makers) vs finished sterile injection sourcing (sterile fill-finish and NDA/ANDA manufacturing). For many hospitals and distributors, “epinephrine injection” and “lidocaine hydrochloride injection” are commonly sourced as finished drugs rather than API, because sterile manufacture drives qualification time.

What companies supply epinephrine API and epinephrine-containing finished injections?

Epinephrine API suppliers (typical coverage)

Epinephrine (CAS 51-43-4) is sold under USP/EP-oriented grades for:

Analytical standards (lower purity, often for lab use)
Pharmaceutical grade API (higher purity, controlled impurities, stable shipping forms)

Common global supplier footprint for epinephrine API includes manufacturers in:

China (large-scale API production)
India (API and intermediate production)
Europe (smaller number of API-oriented suppliers, often with stricter documentation)

Finished-dose supplier footprint often includes companies supplying “Epinephrine Injection USP” or equivalent label strengths and presentations (1 mg/mL and related concentrations, depending on market).

Which dosage forms are most often supplied?

Injectable solution (common for emergency use)
Autoinjector products (less relevant if the scope is “suppliers for epinephrine” as API and injection generally, but suppliers differ materially)
Veterinary epinephrine preparations in some geographies (supplier mix differs)

Supply chain constraints specific to epinephrine

Epinephrine is prone to:

Oxidation-related impurity formation if packaging and headspace oxygen control are weak
Stability and antioxidant strategy requirements for finished sterile solutions

These factors push selection toward suppliers with:

Documented forced degradation and real-time stability packages
Cleanroom and GMP controls for sterile fill-finish when sourcing finished injection

What companies supply lidocaine hydrochloride API and lidocaine hydrochloride finished injectables?

Lidocaine hydrochloride API suppliers (typical coverage)

Lidocaine hydrochloride (CAS 6108-05-0) is a mature API with broad availability in:

USP-grade and EP/Ph. Eur-compatible specs
Injection-focused impurity profiles
Controlled water content and salt form consistency

The global supplier footprint is dense for lidocaine hydrochloride API because it is used across:

Local anesthetic injections
Epidural and regional anesthesia settings
Combination products (with epinephrine, bupivacaine, etc., depending on jurisdiction)

Finished lidocaine hydrochloride products: where supplier risk concentrates

For “lidocaine hydrochloride injection,” the high-impact qualification work is usually:

Sterile manufacturing and aseptic processing capability
Container closure system qualification (leachable/extractables)
Preservative and pH system control (where applicable)
Batch record compliance and release testing coverage

Finished-dose suppliers are often preferred over API sourcing for procurement cycles because:

Hospital qualification already exists at product level
Sterility assurance and container-closure documentation are bundled into the drug application submission package

What is the Orange Book status of epinephrine and lidocaine hydrochloride products?

An Orange Book status analysis requires product-specific identifiers (NDC/active moiety plus dosage form). No complete and accurate listing can be produced from the generic inputs “EPINEPHRINE” and “LIDOCAINE HYDROCHLORIDE” alone because each drug product (strength, dosage form, manufacturer) maps to separate FDA application numbers and patent/exclusivity records.

(When a product is targeted, the Orange Book check is performed at the level of NDA/ANDA and then linked to patents covering the specific strength and dosage form.)

What patents protect epinephrine and lidocaine hydrochloride supplies?

Like Orange Book status, patent protection depends on specific finished products (dosage form, concentration, sterile system, and indication claims). With only the active ingredients provided and without product-level mapping, a complete, accurate patent estate assessment cannot be generated.

What generic entry risks exist for epinephrine and lidocaine hydrochloride?

Epinephrine

Generic entry risk is generally lower when:

Multiple manufacturers already have approved products
Procurement focuses on injection strengths that are well-covered by generics

Risk increases when:

A market has supply constraints at the finished-dose level (sterile fill-finish bottlenecks)
Packaging formats are uncommon or require specialized closure systems

Lidocaine hydrochloride

Entry risk is typically lower because:

The API is widely produced
Injection formulations are well-established

Risk increases where:

Specific concentration/presentation formats are capacity-limited
There are sterile manufacturing constraints or batch rejection incidents affecting supply

How do suppliers differ between epinephrine API and epinephrine finished injection?

Supplier categories

API manufacturers: sell epinephrine chemical API to drug product manufacturers and compounding/rep for some jurisdictions.
Sterile fill-finish manufacturers: procure API and produce finished sterile injections under GMP with validated aseptic processing.
Marketing authorization holders: own the regulatory file and sell the finished product under specific NDC/label claims.

Key qualification artifact difference

API qualification emphasizes impurity profile, assay, polymorph/salt stability (where applicable), and change control.
Finished injection qualification emphasizes sterility assurance, container closure integrity, and stability data under actual storage conditions.

How do suppliers differ between lidocaine hydrochloride API and lidocaine hydrochloride finished injection?

Supplier categories

API suppliers: provide lidocaine hydrochloride salt with consistent impurity limits and controlled manufacturing record.
Sterile injectables suppliers: handle pH control, sterilization strategy, and fill-finish validation.

Typical quality bottlenecks for lidocaine injection

Endotoxin controls and bioburden-to-sterility transfer control (aseptic lines)
Leachables/extractables from syringes/vials
Consistent pH and preservative system for multi-month stability

What manufacturing/IP barriers affect supplier qualification for epinephrine and lidocaine hydrochloride?

Common barriers

GM P inspection readiness across sterile operations
Validation of aseptic processing and sterile filtration strategy (if used)
Change control constraints (process changes at API level require downstream bridging)
Regulatory commitments specific to each NDA/ANDA drug product file

Typical audit focuses

Cleaning validation and cross-contamination controls
Viral/bacterial endotoxin controls for water and sterile operations
Sterility assurance (media fills, environmental monitoring, excursion handling)

Key commercial guidance for choosing suppliers (actionable procurement criteria)

Supplier qualification checklist for epinephrine injection

Stability package aligned to target shelf-life and storage temperature
Oxygen exposure controls and oxidation impurity trend
Container closure system data and compatibility studies
Sterility assurance and batch release testing coverage for the exact NDC

Supplier qualification checklist for lidocaine hydrochloride injection

pH specification consistency and compatibility with diluents (if applicable)
Sterile process validation and endotoxin/bioburden release testing
Leachables/extractables documentation for primary packaging
Stability indicating method alignment with shelf-life

Supplier landscape summary table (form-based)

Active	Form to source	Supplier selection driver	Where constraints typically appear
Epinephrine	API	Impurities, oxidation control, stability under shipping	Oxidation sensitivity, documentation maturity
Epinephrine	Sterile injection	Aseptic process validation, container closure data	Sterile fill-finish capacity, stability of solution
Lidocaine HCl	API	Consistent salt form, impurities, assay	Fewer, more documentation-driven constraints
Lidocaine HCl	Sterile injection	Sterile manufacturing, pH/preservative system	Sterile batch capacity, packaging leachables

Key Takeaways

Supplier availability for lidocaine hydrochloride is typically broader than for epinephrine at the finished sterile product level, because both the API base and sterile manufacturing base are deeper for lidocaine.
For both actives, the most material procurement qualification work is usually tied to finished sterile injections (sterility assurance, packaging compatibility, stability), not the API alone.
Any Orange Book, patent, or litigation mapping must be done at the specific product level (NDA/ANDA and dosage form). Generic active-ingredient inputs are insufficient for a complete status/patent answer.

FAQs

1) What’s the difference between sourcing epinephrine API versus epinephrine injection finished product?

API sourcing shifts qualification to chemical quality, impurities, and stability handoff; finished product sourcing shifts it to sterile process validation, container closure integrity, and FDA release testing for the specific NDC.

2) What quality tests matter most for lidocaine hydrochloride injection?

Impurity profile, pH specification, sterility assurance and endotoxin limits, and leachables/extractables compatibility for vials/syringes.

3) Why can epinephrine supply tighten even when many manufacturers exist?

Epinephrine is oxidation-sensitive and finished sterile operations are capacity constrained in outbreaks or batch quality events, affecting distributor inventory more than API availability.

4) Do different epinephrine strengths have different supplier risks?

Yes. Higher-demand strengths or specific container formats can face localized capacity shortages at the finished-dose level even when API is broadly available.

5) How should procurement teams structure supplier qualification for sterile injectables?

Qualify to the exact marketed strength, container closure system, and release specification tied to the NDA/ANDA batch release tests, then require change-control notifications for manufacturing site and process changes.

References (APA)

No sources were cited because the request did not include product identifiers (NDC, NDA/ANDA, strength, dosage form) needed to produce an accurate supplier list, Orange Book status, or patent estate mapping.

Suppliers and packagers for generic pharmaceutical drug: epinephrine; lidocaine hydrochloride