In the pharmaceutical industry, Chlorpheniramine Maleate (CPM) 4 mg is a first-generation alkylamine antihistamine. As a pharmacist and manufacturer, I classify this as a “Classic H1-Antagonist.” It is a staple molecule in the global market, particularly valued for its potent anti-allergic properties and its role as a key ingredient in multi-drug cold and flu formulations.

At your WHO-GMP facility in Mumbai, you likely manufacture this as a standalone 4 mg tablet or as part of a Fixed-Dose Combination (FDC) with Paracetamol and Phenylephrine.

Primary Clinical Uses

• Allergic Rhinitis: Relieves sneezing, runny nose, and itchy/watery eyes caused by hay fever or environmental allergens.

• Urticaria (Hives): Effectively manages skin rashes and itching.

• Common Cold Symptom Relief: Reduces the nasal discharge and “dripping” associated with viral respiratory infections.

• Anaphylactic Support: Used as an adjunct to adrenaline for treating severe allergic reactions.

• Pruritus: General relief for itching caused by insect bites or certain skin conditions.

Mechanism: The H1-Receptor Blockade

Chlorpheniramine works by competing with histamine for its receptor sites on effector cells.

Competitive Inhibition: It binds to $H_1$ receptors in the blood vessels, GI tract, and respiratory tract.

Stopping the Cascade: By blocking these receptors, it prevents histamine from causing vasodilation, increased capillary permeability (which causes the “runny” nose), and smooth muscle contraction.

CNS Penetration: Because it is highly lipophilic, it crosses the blood-brain barrier easily. This is why Chlorpheniramine 4 mg is known to cause significant sedation or drowsiness compared to second-generation antihistamines like Cetirizine.

Safety & Pharmacist’s Guidance

As a pharmacist, providing these technical warnings on your digital platforms ensures professional credibility:

• Sedation Warning: Patients must be advised not to drive or operate heavy machinery.

• Anticholinergic Effects: Can cause dry mouth, blurred vision, and urinary retention.

• Pediatric Caution: Dosage must be strictly weight-based; the 4 mg tablet is typically for adults and children over 12 years.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai, Chlorpheniramine is a high-volume, strategic asset:

• The FDC Advantage: On your marketplace, highlight your Cold & Flu FDCs. Chlorpheniramine is the “drying agent” that balances the analgesic effect of Paracetamol. Mentioning your content uniformity for such a low-dose (4 mg) API is a major USP for B2B buyers.

• Stability for Export: Chlorpheniramine is relatively stable but light-sensitive. At our facility, we utilize Alu-Alu blister packaging or Amber-colored PVC to ensure a 36-month shelf life, especially for export to Zone IVb tropical regions.

• Cost-Effectiveness: CPM is one of the most affordable antihistamines globally. This makes it the ideal choice for Government Tenders and “Essential Medicine” kits for international NGOs.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in regions like Southeast Asia, Africa, and the Middle East.