Why Farbe Firma is the Top Manufacturer of Midazolam Injection
- Maulik Sudani
- 12 hours ago
- 4 min read
Last Updated: May 14, 2026
TL;DR: Midazolam Injection is a short-acting benzodiazepine used worldwide for pre-anaesthetic sedation, ICU sedation, status epilepticus, and emergency airway management. Farbe Firma manufactures Midazolam Injection at a WHO-GMP certified sterile facility in Gujarat, India, with controlled-substance handling protocols and full CTD/ACTD dossier support for buyers across 30+ countries.
Key Takeaways
WHO-GMP certified sterile manufacturing in Ankleshwar, Gujarat, India
Available as 1 mg/mL and 5 mg/mL ampoules and pre-filled syringes in multiple pack sizes
Controlled-substance regulatory pathway support, including narcotic-licence documentation
Trusted CDMO partner exporting Midazolam Injection to anaesthesia and ICU markets in 30+ countries
Introduction
Midazolam is a fast-onset, short-duration benzodiazepine that has become indispensable in modern anaesthesia and emergency medicine. It is used for conscious sedation in endoscopy and dental procedures, induction of anaesthesia, continuous ICU sedation of ventilated patients, and the parenteral management of acute seizures and status epilepticus. The WHO Model List of Essential Medicines recognizes Midazolam Injection as a core medicine in both adult and paediatric formularies.
Because Midazolam is a controlled substance in most jurisdictions, buyers need a manufacturer who not only delivers pharmacopoeial-grade quality but also navigates the complex licensing and export-permit framework that surrounds benzodiazepines. Farbe Firma Pvt Ltd combines WHO-GMP sterile manufacturing with strict controlled-substance handling — making us a long-standing supplier for hospital anaesthesia programs, ICUs, and government tender authorities.
Manufacturing Excellence for Midazolam Injection
Farbe Firma's Midazolam Injection is produced in dedicated sterile aseptic-fill lines under ISO Class 5 (Grade A) laminar airflow with Class 7 (Grade B) backgrounds, fully compliant with WHO-GMP, revised Schedule M, and ICH Q7. Aseptic process simulations (media-fill runs) are conducted twice yearly for each line, and operator gowning, behaviour, and environmental monitoring follow EU Annex 1 best-practice equivalents.
Active pharmaceutical ingredient Midazolam Hydrochloride is sourced from licensed, audited vendors holding valid narcotics-and-psychotropic-substance permits. Each API batch is received against a Narcotics Department-issued procurement authorization, weighed in a vault-secured dispensing booth, and reconciled at every manufacturing step. Water for Injection is produced in our validated multi-effect still and is endotoxin and TOC monitored every shift.
Available Pack Sizes and Dosage Strengths
Farbe Firma offers Midazolam Injection in the strengths most requested by anaesthesia and ICU buyers globally: 1 mg/mL in 5 mL ampoules for paediatric and conscious-sedation dosing, and 5 mg/mL in 1 mL, 3 mL, and 10 mL ampoules for adult induction and continuous infusion protocols. Pre-filled syringes (PFS) in 5 mg/5 mL and 10 mg/10 mL formats are available for tender markets that have moved to ready-to-administer formats.
All packs use Type-I clear glass ampoules with snap-ring opening, OPC (one-point-cut) scoring, and tamper-evident secondary packaging. Multilingual artwork in English, Spanish, French, Portuguese, Arabic, and Russian is available for buyers serving multi-region distribution networks. Pilot quantities for dossier filing are accepted under appropriate controlled-substance permits.
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Quality Control, Regulatory Support, and Controlled-Substance Compliance
Every Midazolam Injection batch is released only after full QC: HPLC assay against IP/BP/USP, related substances, pH (3.0-3.6 specification), particulate matter (≤6,000 per container ≥10 µm), sterility, and bacterial endotoxins. Three-month accelerated stability and 24-month long-term stability under ICH Zone IVb (30°C/75% RH) are completed for every new SKU. Retention samples are held for shelf life plus one year per Schedule M.
Our regulatory affairs team prepares full CTD and ACTD dossiers including controlled-substance-specific annexes — narcotics-licence copies of the manufacturer, vendor API licences, security and storage SOPs, and import-permit templates customized to the destination country (INCB authorities). We have successfully exported Midazolam Injection under valid narcotic export permits to Latin America, the CIS, Africa, the Middle East, and South-East Asia, and our team supports buyers end-to-end through registration, permit, and post-marketing surveillance phases.
Why Farbe Firma
Farbe Firma Pvt Ltd is a WHO-GMP certified pharmaceutical manufacturer headquartered in Ankleshwar, Gujarat, India. Our purpose-built sterile injectable facility operates ISO Class 5 cleanrooms with validated HVAC, water-for-injection (WFI), and steam systems, and follows ICH Q7-Q10 lifecycle quality standards. Every batch is released after full physicochemical, microbiological, and endotoxin testing in our in-house QC laboratory.
Our portfolio spans 100+ injectables across antibiotics, anti-malarials, anaesthetics, steroids, haematinics, oncology supportives, and life-saving emergency molecules. We currently export to more than 30 countries across Latin America, the CIS, Africa, the Middle East, and South-East Asia, supporting tender supply, private-label CMO programs, and brand-development partnerships with full CTD and ACTD dossier coverage.
What differentiates Farbe Firma is the combination of regulated-market quality systems with the agility of a mid-size Indian manufacturer: short lead times, flexible MOQs, multilingual artwork, and a single-point technical liaison from RFQ to delivery. Buyers benefit from our 30+ years of collective pharma manufacturing experience and a track record of zero major regulatory observations across audits.
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Frequently Asked Questions
Is Farbe Firma licensed to manufacture Midazolam Injection as a controlled substance?
Yes. Farbe Firma holds the required Narcotics and Psychotropic Substances licences from the Central Bureau of Narcotics, India, and operates a Schedule H1 / psychotropic-controlled manufacturing block with vault-secured storage, reconciled dispensing, and CCTV-monitored access.
What strengths and pack sizes of Midazolam Injection do you supply?
We supply 1 mg/mL in 5 mL ampoules and 5 mg/mL in 1 mL, 3 mL, and 10 mL ampoules. Pre-filled syringes in 5 mg/5 mL and 10 mg/10 mL formats are also available for ready-to-administer tender markets.
Do you provide CTD/ACTD dossiers and controlled-substance documentation?
Yes. Our dossiers include the standard CTD/ACTD modules plus controlled-substance annexes — narcotics-licence copies, API vendor permits, security SOPs, and country-specific INCB import-permit templates.
Can you handle export permits to my country?
Yes. Our regulatory team works with the buyer's local INCB authority to arrange the required import permit and matches it to our Indian export permit. We have shipped Midazolam Injection under valid permits to 25+ countries across Latin America, CIS, Africa, the Middle East, and South-East Asia.
How long does it take to receive a quotation for Midazolam Injection?
We respond to RFQs within 24-48 working hours. Because Midazolam is a controlled substance, we ask for a Letter of Intent or distributor-licence copy before sharing detailed pricing and regulatory packages.
Technically Reviewed By: Maulik Sudani | Jignasu Sudani (Technical Expert)
Farbe Firma Pvt Ltd
Website: www.farbefirma.org
Email: director@farbefirma.org
Address: Ankleshwar, Gujarat, INDIA
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