Why Farbe Firma is the Top Manufacturer of Drotaverine HCl Injection
- Maulik Sudani
- 3 days ago
- 7 min read
Last Updated: June 4, 2026
TL;DR: Drotaverine HCl Injection — a sterile aqueous solution of the smooth-muscle antispasmodic drotaverine hydrochloride, supplied most commonly as a 40 mg/2 mL (20 mg/mL) solution in amber-glass ampoules for slow intravenous or intramuscular administration — is a widely used agent for the rapid relief of acute smooth-muscle spasm: biliary and renal (ureteric) colic, gastrointestinal and gastric spasm, dysmenorrhoea and spastic pain in obstetric and gynaecological practice. As an isoquinoline derivative structurally related to papaverine, drotaverine relaxes smooth muscle by selectively inhibiting phosphodiesterase-4 (PDE-4), raising intracellular cyclic AMP independently of autonomic innervation, so it relieves spasm without the anticholinergic burden of antimuscarinic antispasmodics. Because the molecule is light-sensitive and the dose must be exact and particulate-free for parenteral use, its safety depends on a precise stability-indicating assay, a tightly controlled impurity profile, low particulate and endotoxin, light protection and robust ampoule container-closure integrity. Farbe Firma Pvt Ltd manufactures WHO-GMP certified Drotaverine HCl Injection at our Gujarat, India facility and supplies it to hospital pharmacy, emergency, gastroenterology, urology and obstetric services, tenders, distributors and brand owners across 30+ countries.
Key Takeaways
Drug class: Smooth-muscle antispasmodic (selective PDE-4 inhibitor) — Drotaverine HCl Injection gives rapid relief of acute smooth-muscle spasm in biliary and renal (ureteric) colic, gastrointestinal spasm, dysmenorrhoea and obstetric-gynaecological spastic pain, relaxing smooth muscle by raising intracellular cyclic AMP without the anticholinergic burden of antimuscarinic agents.
Certified manufacturing: WHO-GMP certified plant, ISO Class 5 aseptic core, validated water-for-injection loops, qualified ampoule filling lines, dedicated control of the stability-indicating assay, the impurity profile, pH, particulate and endotoxin for a light-sensitive aqueous injection, with light protection and container-closure integrity verification on every batch.
CTD-ACTD dossier support: Full eCTD and ACTD modules, ICH Q1A long-term and accelerated stability data, ICH Q1B photostability data, drug master files and CEP-style documentation for registrations including ministry-of-health, hospital-formulary and institutional tenders.
End-to-end CDMO services: Contract manufacturing, third-party manufacturing, private-label artwork, multilingual leaflets, tender-ready ampoule packaging and logistics coordination for buyers in Africa, LATAM, CIS, GCC, MENA and Southeast Asia.
Introduction: Why Drotaverine HCl Injection Demands a Premium Manufacturer
Drotaverine HCl Injection occupies a busy, high-turnover place in acute care. It is the parenteral antispasmodic that emergency physicians, gastroenterologists, urologists and obstetricians reach for when a patient arrives in severe, colicky pain — the wrenching spasm of a gallstone lodged in the biliary tree, a calculus passing down the ureter, an acute gastrointestinal spasm, or the cramping of dysmenorrhoea and certain obstetric situations. Given by slow intravenous or intramuscular injection, it works quickly to relax the spastic smooth muscle and break the pain cycle. In every one of these settings the patient is acutely distressed, the clinician needs a fast and predictable response, and the dose delivered from each ampoule must be accurate, sterile and reliably the same from unit to unit.
That clinical reality places real demands on the manufacturer. Drotaverine hydrochloride is a coloured, light-sensitive isoquinoline base whose injectable solution must stay clear, correctly potent and free of degradation products across its shelf life. The assay must be exact — an under-potent ampoule fails the patient in acute pain, while degradation or impurity above limits is unacceptable in a parenteral. The solution must be particulate-free, low in endotoxin, held at the right pH for tolerability, protected from light in amber glass, and sealed in an ampoule whose integrity is verified. Choosing a Drotaverine HCl Injection manufacturer that treats the stability-indicating assay, impurity profiling, light protection, particulate and endotoxin control and container-closure integrity as core engineering disciplines is what protects the patient at the point of care.
What Sets a World-Class Drotaverine HCl Injection Manufacturer Apart
A world-class manufacturer of Drotaverine HCl Injection invests in three areas that weaker suppliers underfund: a precise, stability-indicating assay of drotaverine hydrochloride together with tight control of its related-substance and degradation-product profile by HPLC for a light-sensitive molecule, robust aseptic filling of a coloured aqueous solution into amber-glass ampoules with verified container-closure integrity, and tender-ready dossier support for a product procured largely through hospital-formulary, emergency-medicine and ministry-of-health channels. It starts with the active — pharmacopoeial-grade drotaverine hydrochloride sourced from qualified, audited API makers, with full assay, related-substance and impurity profiling and certificates of analysis verified by the receiving laboratory before the material enters production.
Formulation, filling and sealing then have to preserve both the assay and the dose. The bulk solution is compounded in water-for-injection at controlled pH, protected from light throughout, sterile-filtered through 0.22 µm membrane and filled aseptically into amber-glass ampoules under ISO Class 5 air. The filling and sealing parameters are locked in the master batch record, because for a light-sensitive antispasmodic the assay and the degradation-product profile govern both the efficacy and the safety of every ampoule. Each ampoule is fusion-sealed and 100 % inspected for particulate matter, fill volume, seal quality and cosmetic defects; in-process and release testing confirm drotaverine assay by validated HPLC, the related-substance profile, pH, clarity and colour of the solution, and endotoxin is held well within limits so the injection is safe for slow intravenous or intramuscular administration.
Quality Systems Behind Every Drotaverine HCl Injection
Every Farbe Firma Drotaverine HCl Injection batch is released only after a full stack of quality checks: stability-indicating HPLC assay of drotaverine hydrochloride against USP, BP, IP or EP reference standards, control of related substances and degradation products by HPLC, pH and osmolarity, clarity and colour of the solution, visible and sub-visible particulate matter, bacterial endotoxin by LAL, sterility by membrane filtration, fill-volume verification and container-closure integrity for the ampoule format. Certificates of analysis are issued with full traceability back to the API lot, the primary-packaging lot and the qualified person responsible for release.
Around those release tests sits a deeper quality architecture: validated water-for-injection generation and looped distribution, qualified HVAC with continuous environmental monitoring, calibrated sterilisation and depyrogenation equipment, validated ampoule filling lines with 100 % inspection, and an electronic batch record system tied into our deviation, change-control and CAPA workflows. Because drotaverine is light-sensitive and its assay and degradation profile drive both efficacy and shelf life, we treat the stability-indicating HPLC assay and the degradation-product result as critical quality attributes and trend them across batches, not merely as one-off release tests. Stability is tracked under both long-term (30 °C / 65 % RH) and accelerated (40 °C / 75 % RH) ICH Q1A conditions, with ICH Q1B photostability challenge, and the product is protected from light through amber glass and its secondary packaging.
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Why Farbe Firma is the Trusted Drotaverine HCl Injection manufacturer for Global Buyers
Farbe Firma Pvt Ltd manufactures more than 100 sterile injectables across antispasmodic, gastrointestinal, analgesic, anti-infective, critical-care and supportive-care categories. For Drotaverine HCl Injection specifically, we supply the 40 mg/2 mL (20 mg/mL) amber-glass ampoule presentation under WHO-GMP conditions, with country-specific strengths, fill volumes and pack configurations available under contract manufacturing agreements. Every batch is released to WHO-GMP standards, with the underlying CTD or ACTD dossier — including the stability-indicating-assay and impurity data package — ready to hand for registration and tender qualification.
Our CDMO services scale cleanly from single-hospital supply to full national tender procurement. We prepare complete eCTD and ACTD modules, drug master files, ICH Q1A stability and ICH Q1B photostability packages, assay and related-substances method-validation data, translated package inserts and artwork for Spanish, French, Portuguese, Russian and Arabic markets, and coordinate shipping and logistics. When a buyer needs Drotaverine HCl Injection at tender scale our regulatory, manufacturing and logistics teams move as one: dossier, validation reports, artwork, filling-line slot and shipment plan delivered as a single coordinated package.
Buyers stay with Farbe Firma because of audit-readiness and communication. Customer auditors are welcomed onto the plant floor and into the filling suite; our quality unit answers technical queries with primary data, not slogans; and our reviewer team — practising pharmacists and R&D scientists — can talk through API sourcing, stability-indicating assay development, related-substance and degradation control, light protection, particulate and endotoxin control, container-closure integrity, photostability and shelf-life choices in real detail. For a fast-acting parenteral antispasmodic given to patients in acute colicky pain, where assay accuracy and impurity control directly govern both relief and safety, that openness is exactly what global buyers tell us they value most.
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Frequently Asked Questions (FAQ)
Is Farbe Firma a WHO-GMP certified Drotaverine HCl Injection manufacturer?
Yes. Farbe Firma Pvt Ltd holds WHO-GMP certification and manufactures Drotaverine HCl Injection at a Gujarat, India facility with ISO Class 5 aseptic processing, qualified amber-glass ampoule filling lines, qualified water-for-injection systems, 100 % ampoule inspection and continuous environmental monitoring.
Which strengths and pack sizes of Drotaverine HCl Injection do you supply?
Our standard presentation is a 40 mg/2 mL (20 mg/mL) sterile aqueous solution in amber-glass ampoules. Custom strengths, fill volumes, ampoule counts per pack and country-specific artwork are available under contract manufacturing agreements.
Can Farbe Firma support country-specific registrations for Drotaverine HCl Injection?
Yes. We provide full CTD and ACTD dossier modules, drug master files, ICH Q1A stability and ICH Q1B photostability packages, assay and related-substances method-validation data, and translated package inserts and artwork for Spanish, French, Portuguese, Russian and Arabic markets. We support registrations and tender qualification in 30+ countries across Africa, LATAM, CIS, GCC, MENA and Southeast Asia.
How does Farbe Firma assure the quality and safety of Drotaverine HCl Injection?
We control the assay and related substances by stability-indicating HPLC against pharmacopoeial standards, verify pH, clarity and colour, hold endotoxin well within limits by LAL, run particulate and sterility testing, 100 %-inspect every ampoule, verify container-closure integrity, protect the product from light through amber glass, and qualify each batch against ICH Q1A and ICH Q1B protocols.
What is the minimum order quantity for Drotaverine HCl Injection contract manufacturing?
MOQs vary by ampoule size, fill volume, label complexity and dossier requirements. For our ampoule presentations we accommodate hospital-scale and full national-tender-scale orders. Contact director@farbefirma.org for a specific quotation.
Technically Reviewed By: Maulik Sudani | Jignasu Sudani (Technical Expert)
Website: www.farbefirma.org | Email: director@farbefirma.org | Address: Gujarat, INDIA
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