Gastrointestinal & Antiulcer

Drotaverine HydrochlorideThird Party Manufacturing in India

Looking to get Drotaverine Hydrochloride manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
985-12-6
Drug Class
Benzylisoquinoline antispasmodic (PDE4 inhibitor)
Molecular Formula
C₂₄H₃₁NO₄·HCl
Molecular Weight
433.97 g/mol
Grade Standards
IP, BP
Therapeutic Category
Gastrointestinal & Antiulcer
MOQ
10,000 ampoules per batch
Dosage Forms
Injection

Mechanism of Action

Drotaverine Hydrochloride works by directly relaxing smooth muscle tissue to relieve painful spasms and cramps throughout the body.

The molecule acts as a selective inhibitor of the phosphodiesterase-4 (PDE4) enzyme, which is responsible for breaking down cyclic adenosine monophosphate (cAMP) in smooth muscle cells. By blocking PDE4, drotaverine increases intracellular cAMP levels, which in turn inactivates myosin light chain kinase. This prevents the phosphorylation of myosin and blocks muscle contraction, resulting in smooth muscle relaxation. Additionally, it exhibits mild calcium channel blocking properties, reducing calcium entry into cells to further promote relaxation.

Unlike anticholinergic antispasmodic drugs, Drotaverine Hydrochloride does not block acetylcholine receptors. This key differentiator allows it to relieve smooth muscle spasms without causing dry mouth, blurred vision, or urinary retention. It is highly effective and well-tolerated for patients experiencing gastrointestinal, biliary, or genitourinary colicky pain.

Therapeutic Uses & Indications

Therapeutic Uses

Drotaverine Hydrochloride is prescribed for the treatment of:

  • Gastrointestinal Spasms: Relieves abdominal pain associated with irritable bowel syndrome (IBS), enteritis, gastritis, and peptic ulcers.
  • Biliary Colic: Indicated for spasms of the biliary tract due to cholelithiasis, cholecystitis, and cholangitis.
  • Renal Colic: Used to manage acute, severe pain caused by kidney stones, ureterolithiasis, and cystitis.
  • Obstetric and Gynecological Spasms: Prescribed for painful menstruation (dysmenorrhea) and to facilitate cervical dilation during labor.

Why Manufacturers Choose Drotaverine Hydrochloride

Drotaverine Hydrochloride is a highly popular antispasmodic molecule with steady year-round demand in Asian, Eastern European, and Latin American markets. Since it provides rapid pain relief without anticholinergic side effects, it is a preferred choice for clinicians managing acute colic. For third party manufacturers, producing Drotaverine Hydrochloride injections (40mg/2ml) offers a high-volume liquid injectable line with strong market penetration. Sourcing from a WHO-GMP certified facility in India ensures sterile ampoule filling, stable formulation chemistry, and professional packaging suited for global distribution networks.

This makes Drotaverine Hydrochloride one of the most sought-after antispasmodics for third party manufacturing in India, with consistent demand from PCD franchise operators and retail distributors.

Dosage Forms We Manufacture

Injection
40mg/2ml

Frequently Asked Questions

What is the minimum order quantity for Drotaverine Hydrochloride?
Minimum order quantity for Drotaverine Hydrochloride is 10,000 ampoules per batch. Please contact us for bulk pricing and custom quantities.
What dosage forms of Drotaverine Hydrochloride can you manufacture?
We manufacture Drotaverine Hydrochloride as: Injection (40mg/2ml).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Drotaverine Hydrochloride for export?
Yes. We provide export-ready Drotaverine Hydrochloride formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Drotaverine Hydrochloride?
We manufacture Drotaverine Hydrochloride to IP, BP pharmacopoeial standards.
Third Party Manufacturing

Get Drotaverine Hydrochloride made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • MOQ from 10,000 ampoules per batch
Get a Manufacturing QuoteWhatsApp Us Now

+91 9689237122 · replies within hours

Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Amber glass ampoules (2ml), packed in trays of 5 or 10 ampoules inside a printed mono carton.

Start Manufacturing Drotaverine Hydrochloride Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Drotaverine Hydrochloride across all dosage forms. PCD franchise and export orders welcome.

Need something? Chat with us!