Promethazine

Promethazine is a versatile and widely used first-generation antihistamine belonging to the phenothiazine group. With antihistaminic, antiemetic, sedative, and anticholinergic properties, it is used in a wide range of clinical settings, including allergy management, motion sickness, nausea, vomiting, and even pre-operative sedation. Due to its broad utility across age groups and therapeutic indications, Promethazine remains an essential medicine in many healthcare systems.

At BluepillExpress, we provide comprehensive third-party manufacturing services for Promethazine, catering to pharmaceutical marketers, global distributors, hospital suppliers, and government tenders. Our world-class manufacturing infrastructure, regulatory capabilities, and global export proficiency make us a trusted partner for private label production and large-scale formulation supply.

About BluepillExpress

BluepillExpress is a WHO-GMP certified global manufacturer and exporter of quality pharmaceutical formulations. With a presence in over 25 countries across Asia, Africa, CIS, Latin America, and the Middle East, we specialize in third-party manufacturing services that are customizable, compliant, and scalable.

Our services include:

• End-to-end formulation development and production
• Custom branding, private labeling, and packaging
• Regulatory dossier support and documentation
• Supply chain and export management
• Fast turnaround time with batch consistency

We are committed to delivering cost-effective, high-quality, and regulatory-compliant medicines that meet the needs of dynamic healthcare markets.

Product Overview: Promethazine

Promethazine is a H1 receptor antagonist that is effective in treating allergic conditions, nausea, motion sickness, and insomnia. It is also used for its sedative and anxiolytic effects in preoperative and procedural sedation. Promethazine is on the World Health Organization’s List of Essential Medicines, highlighting its significance in basic healthcare.

Indications:

• Allergic rhinitis, hay fever, and urticaria
• Anaphylaxis (adjunct to epinephrine)
• Motion sickness and travel-related nausea
• Post-operative and chemotherapy-induced nausea and vomiting
• Insomnia and short-term sedation
• Pre-anesthesia and procedural sedation
• Cough and cold formulations (as a sedative component)

Mechanism of Action

Promethazine acts by blocking H1 histamine receptors in peripheral tissues and the central nervous system. Additionally, it has:

• Anticholinergic effects: Helps dry secretions in allergic reactions
• Sedative effects: Due to CNS depressant action
• Dopamine receptor antagonism: Contributes to antiemetic effect

This multifaceted pharmacology makes Promethazine a preferred agent across several therapeutic domains.

Available Dosage Forms

BluepillExpress offers Promethazine in multiple dosage forms to suit various medical needs and regulatory requirements. All formulations comply with IP, BP, USP, or Ph. Eur. specifications.

1. Promethazine Hydrochloride Tablets

• 10 mg, 25 mg
• Film-coated or sugar-coated
• Blister or strip packaging
• Scored tablets for dose adjustment

2. Promethazine Syrup / Oral Solution

• 5 mg/5 ml or 6.25 mg/5 ml
• Alcohol-free, sugar-free options available
• Pediatric-friendly flavors (orange, cherry, mint)
• Bottle sizes: 60 ml, 100 ml, 200 ml

3. Promethazine Injection

• 25 mg/ml or 50 mg/ml
• 1 ml and 2 ml ampoules
• Sterile, clear solution for IV/IM administration
• Used for severe nausea or procedural sedation

4. Combination Formulations (on request)

• Promethazine + Dextromethorphan (Cough Syrup)
• Promethazine + Paracetamol (Cold & Flu Formulation)
• Promethazine + Codeine (Controlled combinations in permitted markets)

All formulations are supported with validated analytical methods, stability data, and regulatory documentation.

Packaging Solutions

BluepillExpress provides customized, export-ready packaging designed to meet the needs of diverse markets and customer preferences.

Tablets:

• Blister packs (PVC/Alu or Alu-Alu)
• Strip packs with printed foil
• Mono cartons with multilingual inserts

Syrup / Solution:

• HDPE or PET bottles with measuring caps
• Child-resistant closures
• Outer carton with dosing guide
• Spoon or oral syringe included

Injections:

• Amber or clear glass ampoules
• Tray packs of 5×2 ml or 10×1 ml
• Carton with leaflet and dosage instructions

All packaging is designed for safety, tamper evidence, UV protection, and shelf-life assurance.

Manufacturing Infrastructure

Our WHO-GMP certified production facilities are equipped with advanced technology and automation to ensure precision, compliance, and efficiency.

Key capabilities include:

• Tablet compression and film-coating lines
• Liquid and syrup filling lines with homogenization units
• Ampoule filling and sealing machines (fully automated)
• HVAC-controlled cleanroom environments
• Water purification systems (RO + UV + Ozone)
• Quality-controlled warehouse with climate zones

All processes are governed by robust Standard Operating Procedures (SOPs) to minimize deviations and optimize quality.

Quality Assurance and Quality Control

BluepillExpress maintains strict QA/QC protocols at every stage of manufacturing, from raw material sourcing to final packaging.

Our quality control includes:

• API identity and potency testing
• In-process checks for content uniformity, pH, viscosity (liquids), and sterility (injectables)
• Finished product testing:
  • Assay and impurity profiling
  • Dissolution and disintegration
  • Microbial limits
  • Container-closure integrity
  • Real-time and accelerated stability studies

All products meet pharmacopeial standards (IP, BP, USP, Ph. Eur.) and comply with ICH Q1A stability guidelines and ISO 9001:2015 quality management standards.

Regulatory Documentation Support

To help clients navigate global markets, we offer complete regulatory support, including:

• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Analysis (CoA)
• Stability data and shelf-life documentation
• Manufacturing license and WHO-GMP certificate
• Free Sale Certificate
• Method validation protocols
• MSDS (Material Safety Data Sheet)
• CTD or ACTD dossiers for regulatory approval

Our experienced regulatory team ensures timely delivery of documents and guidance throughout the product registration process.

Export Capabilities and Global Reach

We currently export Promethazine formulations to a wide range of countries and are well-versed in the export requirements of regulated and semi-regulated markets.

Our export services include:

• Multilingual labeling (English, French, Spanish, Arabic, etc.)
• Regulatory document preparation and notarization
• Customs clearance and shipping via air or sea
• Cold chain management (for injectables)
• WHO-tender and NGO supply readiness

Target regions include:

• Africa: Kenya, Ghana, Ethiopia, Nigeria, South Africa
• Asia: Sri Lanka, Myanmar, Vietnam, Philippines
• Middle East: Iraq, Jordan, UAE, Saudi Arabia
• CIS: Kazakhstan, Uzbekistan, Georgia
• LATAM: Bolivia, Peru, Dominican Republic

Ideal Clients and Applications

Our Promethazine manufacturing services are ideal for:

• Generic pharmaceutical companies
• OTC and branded formulation marketers
• Hospitals and healthcare institutions
• Retail pharmacy chains
• Public health programs and NGOs
• Distributors seeking private label supply
• Government tenders and humanitarian aid programs

We support low minimum order quantities (MOQs) for growing brands and provide bulk supply for large-scale procurement.

Why Partner with BluepillExpress?

1. WHO-GMP Certified Manufacturing Facilities
   Trusted by clients in over 25 countries for quality pharmaceutical production.
2. Comprehensive Dosage Range
   Tablets, syrups, injectables, and fixed-dose combinations available.
3. Full Regulatory and Documentation Support
   CTD dossiers, CoPPs, and compliance documents provided.
4. Flexible MOQs and Competitive Pricing
   Scalable for startups, NGOs, and large institutions.
5. Custom Branding and Packaging
   Multilingual, tamper-proof, export-ready formats.
6. Efficient Global Logistics and Exports
   Seamless shipping and registration support across continents.

Conclusion

Promethazine remains a cornerstone medication in allergy management, nausea control, and sedation. Its efficacy, cost-effectiveness, and wide safety margin make it a critical part of many essential drug lists worldwide.

With BluepillExpress, you get a manufacturing partner that understands the regulatory, clinical, and commercial demands of Promethazine production. We combine technical excellence, regulatory strength, and global logistics to offer you unmatched third-party manufacturing services.