Description

Pheniramine Maleate Tablets (25mg / 50mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Pheniramine Maleate Tablets in India. Pheniramine is a classic, widely trusted First-Generation Antihistamine (Alkylamine derivative). It is synonymous with rapid relief from allergic conditions, including Hay Fever (Allergic Rhinitis), Urticaria (Hives), and drug rashes.

We offer Contract Manufacturing (Third Party) services for this high-volume OTC and prescription drug. Pheniramine is known for its efficacy but also for being light-sensitive. Our WHO-GMP certified facility in Mumbai utilizes specialized light-shielded granulation and coating lines to ensure the product remains stable and potent. Healthy Inc manages the export logistics, supplying pharmacy chains and hospitals across Africa, the Middle East, and Southeast Asia, where it remains a staple medication (often recognized under the legacy brand “Avil”).

2. Product Specifications

3. Manufacturing Technology

Stability and patient compliance are prioritized.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Sugar Coating: We often utilize traditional Sugar Coating technology for this product. This not only provides an excellent barrier against moisture and oxygen but also completely masks the bitter taste of the maleate salt, making it easier to swallow.

  • Photosensitivity Protection: Pheniramine degrades if exposed to UV light. We use opaque coating materials and manufacture under controlled lighting to ensure stability.

  • Dissolution: Despite the coating, we optimize the core tablet to disintegrate rapidly in the stomach, ensuring the onset of action occurs within 30 minutes.

• The Exporter: Healthy Inc

  • Tropicalized Packaging: We utilize high-barrier PVC/PVDC or Alu-PVC Blisters to protect the product in hot and humid export markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation products to ensure safety over the 3-year shelf life.

5. Why Use Pheniramine?

It is the “Old Reliable” for acute allergies.

• Mechanism: It competitively blocks Histamine H1-receptors. By preventing histamine from binding to these receptors, it stops the symptoms of allergy (itching, runny nose, swelling, and redness).

• Key Indications:

  • Allergic Rhinitis: Runny nose, sneezing, and watery eyes.

  • Skin Allergies: Urticaria (hives), eczema, and insect bites.

  • Angioedema: Rapid swelling of the skin (often used with steroids).

  • Motion Sickness: (Secondary use) Mild antiemetic effect for travel sickness.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Pheniramine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Avil?

  A: Avil is a brand name (Sanofi). We manufacture the Generic Equivalent (Pheniramine Maleate), which contains the exact same active ingredient and works the same way.

• Q: Does it cause drowsiness?

  A: Yes. As a first-generation antihistamine, it crosses the blood-brain barrier and causes sedation. Do not drive or operate machinery after taking it.

• Q: Can I take it for a cold?

  A: It helps dry up secretions (runny nose) due to its anticholinergic side effects, so it is often found in cold & flu combinations.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 25mg to 50mg, two to three times daily.

• Children (5-10 years): 10mg to 25mg, two to three times daily.

• Administration: Swallow whole with water. Taking with food may reduce stomach upset.

9. Side Effects and Precautions

• Sedation: Drowsiness, dizziness, and lassitude.

• Anticholinergic: Dry mouth, blurred vision, urinary retention (caution in men with enlarged prostate).

• Glaucoma: Use with caution in patients with narrow-angle glaucoma.

• Alcohol: Avoid alcohol. It significantly increases the sedative effect.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light.