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Why Farbe Firma is the Top Manufacturer of Lidocaine Injection

  • Writer: Maulik Sudani
    Maulik Sudani
  • May 15
  • 4 min read

Last Updated: May 15, 2026

TL;DR: Farbe Firma Pvt Ltd manufactures sterile Lidocaine Injection (1%, 2%) at its WHO-GMP certified facility in Ankleshwar, Gujarat — supplying ampoules and vials for local anesthesia and antiarrhythmic use to buyers across 30+ countries.

Key Takeaways

  • Lidocaine Hydrochloride Injection is one of the most widely used local anesthetics in surgery, dentistry, and emergency cardiac care.

  • Farbe Firma manufactures 1% and 2% Lidocaine HCl Injection in ampoules and multi-dose vials with and without adrenaline.

  • Our ISO Class 5 cleanrooms and validated aseptic filling lines support consistent sterility, low particulate counts, and stable shelf life.

  • We supply Lidocaine Injection with full CTD/ACTD dossiers to hospital tenders, dental distributors, and government health agencies in 30+ countries.

Introduction

Lidocaine Hydrochloride Injection is a workhorse local anesthetic. From minor dermatological procedures to dental nerve blocks, from epidural top-ups to emergency-room ventricular arrhythmia management, lidocaine is on virtually every essential-medicines list — including the WHO Model List of Essential Medicines. That ubiquity makes consistent supply, stable formulation, and predictable regulatory documentation non-negotiable for any serious importer.

Farbe Firma Pvt Ltd produces sterile Lidocaine HCl Injection at its WHO-GMP certified facility in Ankleshwar, Gujarat. We have manufactured lidocaine ampoules and multi-dose vials for over a decade and routinely supply hospital chains, dental distributors, and ministry-of-health tenders across Africa, the Middle East, Southeast Asia, and Latin America.

Formulations We Manufacture

We offer Lidocaine Hydrochloride Injection in the strengths and presentations the global market actually buys: 1% (10 mg/mL) and 2% (20 mg/mL), as plain solutions and as Lidocaine + Adrenaline (Epinephrine) 1:80,000 / 1:100,000 / 1:200,000 combinations for dental and surgical use. Primary packaging includes 2 mL and 5 mL clear glass ampoules (Type I borosilicate), 20 mL and 30 mL multi-dose vials with bromobutyl stoppers and aluminum flip-off seals, and 1.8 mL self-aspirating dental cartridges on request.

Each presentation has its own validated stability dossier. Plain lidocaine carries a 36-month shelf life at controlled room temperature; combination products with adrenaline carry 24 months in light-protected packaging because of catecholamine oxidation. Our ICH Zone IVb stability program supports tropical-market registration without additional buyer-side studies.

Quality Control and Sterility Assurance

Sterility is non-negotiable for an injectable used in epidural space, intraoral injection, and IV infusion. Every batch of Lidocaine Injection at Farbe Firma is filled under ISO Class 5 conditions inside ISO Class 7 supporting cleanrooms, with continuous viable and non-viable particulate monitoring. Filled containers undergo 100% visual inspection for particulates, fill volume, and seal integrity.

Analytical release testing follows BP/USP/IP monographs and includes lidocaine assay by HPLC, related substances, pH, particulate matter by light obscuration, bacterial endotoxin by LAL gel-clot, and sterility by membrane filtration with 14-day incubation. Each batch ships with a full Certificate of Analysis and our manufacturing release.

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Registration and Export Support

We supply Lidocaine Injection with complete regulatory packages in CTD (for ROW, GCC, CIS markets) or ACTD format (for ASEAN), accompanied by a Certificate of Pharmaceutical Product, Free Sale Certificate, manufacturing license, and our valid WHO-GMP certificate. For dental cartridge SKUs, we additionally provide validation reports for the self-aspirating closure system.

Our regulatory affairs team coordinates directly with the buyer's local consultant to keep dossier responses fast — typically within five working days for clarification queries from regulators. Country-specific artwork, including pictograms, multilingual labels, and tactile braille for the European market, is supported.

Clinical Use Cases Our Customers Order For

Our buyers use Farbe Firma Lidocaine Injection across the full clinical spectrum: infiltration anesthesia for minor surgery and wound suturing, peripheral nerve blocks, epidural and spinal anesthesia (with preservative-free SKUs), dental local anesthesia using the adrenaline combination cartridges, topical airway anesthesia for endoscopy, and intravenous lidocaine as a second-line antiarrhythmic for ventricular tachycardia in emergency cardiology.

Because lidocaine is on the WHO Model List of Essential Medicines, our hospital-tender buyers also use it to fulfill universal essential-medicines compliance for accreditation bodies like ISQua, JCI, and national hospital accreditation councils. The dossier package we supply makes that compliance audit trail straightforward.

Why Farbe Firma

Farbe Firma Pvt Ltd is a WHO-GMP certified pharmaceutical injectable manufacturer based in Ankleshwar, Gujarat, India. Our facility manufactures 100+ sterile injectables across therapeutic categories — anesthetics, antibiotics, antimalarials, emergency medications, and oncology support — for buyers in 30+ countries. ISO Class 5 aseptic cores, validated CIP/SIP utilities, and a dedicated team of formulation scientists let us scale runs from 25,000 ampoules pilot batches to multi-shift commercial supply.

As a CDMO partner, we deliver more than ampoules. We deliver a packaged dossier strategy, country-specific artwork, post-approval lifecycle management, and a regulatory inspection track record that buyers can rely on. Our facility has been audited by multiple national regulatory authorities (Ghana FDA, Nigeria NAFDAC, Kenya PPB, Yemen SBDMA) and consistently passes with no critical findings.

If you are a hospital group, a dental distributor, a ministry-of-health buyer, or a CDMO sponsor looking for reliable Lidocaine Injection supply, Farbe Firma offers the manufacturing capability, the dossier support, and the operational discipline to keep your supply chain predictable.

Explore Farbe Firma: Products | Global Reach | About Us

Frequently Asked Questions

Which strengths of Lidocaine Injection do you manufacture?

We manufacture Lidocaine HCl 1% (10 mg/mL) and 2% (20 mg/mL), as plain solutions and as Lidocaine + Adrenaline combinations at 1:80,000, 1:100,000, and 1:200,000 ratios.

What pack sizes are available?

Primary packaging includes 2 mL and 5 mL ampoules, 20 mL and 30 mL multi-dose vials, and 1.8 mL self-aspirating dental cartridges on request. Secondary packaging is customizable.

Do you provide registration dossiers?

Yes. We provide complete CTD dossiers (for ROW, GCC, CIS) and ACTD dossiers (for ASEAN), along with CPP, Free Sale Certificate, manufacturing license, and WHO-GMP certificate.

What is the shelf life of your Lidocaine Injection?

Plain Lidocaine Injection has a 36-month shelf life at controlled room temperature. Lidocaine + Adrenaline combinations carry 24 months in light-protected packaging.

Can you support private-label Lidocaine Injection?

Yes. We offer private-label and contract manufacturing — your brand, your artwork, your country-specific marketing authorization holder details — across all our Lidocaine SKUs.

Farbe Firma Pvt Ltd | Gujarat, India | director@farbefirma.org | www.farbefirma.org

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