Diphenoxylate Hydrochloride and Atropine Sulphate Tablets 2.5mg+0.025mg

Diphenoxylate Hydrochloride and Atropine Sulphate Tablets 2.5mg+0.025mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Diphenoxylate Hydrochloride and Atropine Sulphate Tablets IP 2.5mg+0.025mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Diphenoxylate Hydrochloride and Atropine Sulphate Tablets IP 2.5mg+0.025mg
Each uncoated tablet contains:
Diphenoxylate Hydrochloride IP
Equivalent to Diphenoxylate……………2.5mg
Atropine Sulphate IP
Equivalent to Atropine……………………..0.025mg
Excipients………………………………………….q.s. 

THERAPEUTIC INDICATIONS:

This medication is used to treat diarrhea. It helps to decrease the number and frequency of bowel movements. It works by slowing the movement of the intestines. Diphenoxylate is similar to opioid pain relievers, but it acts mainly to slow the gut. Atropine belongs to a class of drugs known as anticholinergics, which help to dry up body fluids and also slow gut movement.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

 WARNING : NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A registered medical practitioner.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light and moisture.
Dosage: As directed by the Physician.

Introduction to Diphenoxylate Hydrochloride and Atropine Sulphate Tablets 2.5mg+0.025mg

Diphenoxylate Hydrochloride and Atropine Sulphate Tablets 2.5mg+0.025mg are a widely prescribed anti-diarrheal combination used in the treatment of moderate to severe diarrhea in adults. Diphenoxylate works by slowing intestinal movement, allowing more water to be absorbed from the stool, while atropine is added in a sub-therapeutic dose to discourage abuse.

Globally, diarrheal diseases remain a major public health concern, particularly in developing and emerging economies. According to international health data, diarrhea is among the top causes of morbidity worldwide, driving consistent demand for safe, effective, and affordable treatments. As a result, Diphenoxylate Hydrochloride and Atropine Sulphate Tablets manufacturers in India play a vital role in supplying regulated and semi-regulated markets.

Taj Pharma, the well-known Diphenoxylate Hydrochloride and Atropine Sulphate Tablets 2.5mg+0.025mg Manufacturer in India, assures high quality, purity, and international regulatory compliance, making it a trusted partner for global buyers.

A Trusted Manufacturer from Vapi, Gujarat, India

Taj Pharma Ltd. India is a well-established Manufacturer, Exporter, and Supplier of Diphenoxylate Hydrochloride and Atropine Sulphate Tablets 2.5mg+0.025mg from Vapi, Gujarat, India. The company is known for its consistent quality, ethical manufacturing practices, and strong export capabilities.

This prescription combination is commonly dosed as two tablets up to four times daily, strictly under medical supervision. It is contraindicated in children under six years of age, highlighting the importance of controlled manufacturing and responsible distribution—areas where Taj Pharma excels.

Therapeutic Uses, Dosage & Administration

Diphenoxylate Hydrochloride and Atropine Sulphate Tablets 2.5mg+0.025mg are used to:

• Treat acute and chronic diarrhea

• Reduce intestinal motility

• Improve stool consistency

The tablets are taken orally with a glass of water. Dosage is individualized based on the severity of diarrhea and patient response, as prescribed by a physician.

Safety Profile & Potential Side Effects

Like all prescription medicines, this combination may cause side effects in some individuals. Reported effects include:

• Indigestion and constipation

• Dry mouth

• Flushing of skin

• Blurred vision

• Drowsiness or dizziness

• Confusion

• Difficulty in urination

• Bronchoconstriction

Rare but serious effects may include:

• Pancreatitis

• Vomiting or worsening diarrhea

• Appetite loss

• Extreme lethargy

• Jaundice (yellowing of skin or eyes)

• Fever and tachycardia in overdose cases

Patients are advised to use the medication strictly as prescribed and consult a healthcare professional if unusual symptoms occur.

In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

Taj Pharma supports smooth international registrations by providing:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• Manufacturing License

• Certificate of Analysis (COA)

• Stability Data

• Batch Manufacturing Records

• CTD / eCTD Dossiers (on request)

Custom Packaging & Labeling

• Blister packs, Alu-Alu, or strip packaging

• Bottles for institutional supply

• Buyer-specific branding

• Multilingual labeling as per importing country regulations

• Serialization support where required

Shelf-Life, Storage & Dosage Form

• Dosage Form: Tablet

• Strength: 2.5mg + 0.025mg

• Shelf Life: 36 months

• Storage: Store below 25°C, protected from moisture and light

Export Certifications

• WHO-GMP

• ISO 9001:2015

• COPP

• CTD Dossier support

• EU-GMP (through associate facilities, if required)

Target Countries & Export Markets

Taj Pharma exports Diphenoxylate Hydrochloride and Atropine Sulphate Tablets from India to:

• Africa

• Southeast Asia

• Middle East

• CIS countries

• Latin America

Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

State-of-the-Art Manufacturing

• WHO-GMP compliant manufacturing units

• Automated tablet compression and coating lines

• In-process and finished product quality checks

• Strict pharmacovigilance systems

Affordable Pricing & Quality Assurance

• Competitive export pricing

• Consistent batch-to-batch quality

• Robust QA/QC procedures

• Compliance with international pharmacopeial standards

Global Presence & Supply Chain Support

• Efficient logistics and cold-chain-free shipping

• Timely deliveries across continents

• Regulatory assistance for market entry

• Long-term supply agreements

Top 20 Countries Taj Pharma Exports To

India , Bangladesh, Nepal, Sri Lanka, Vietnam, Philippines, Cambodia, Nigeria, Kenya, Ghana, Egypt, Ethiopia, Morocco, Peru, Colombia, Ecuador, Bolivia , Ukraine, Uzbekistan, Kazakhstan

Technical Product Specification Table

PAN India & Mumbai Supply Leadership

Taj Pharma is a PAN India Manufacturer and Supplier with strong distribution networks in:

• Mumbai, Maharashtra

• Gujarat

• Delhi NCR

• Hyderabad

• Chennai

Recognized as a Leading  Diphenoxylate Hydrochloride and Atropine Sulphate Tablets 2.5mg+0.025mg Manufacturer & Supplier in India, the company also offers PCD Pharma Franchise opportunities with monopoly rights and marketing support.

Call to Action 

If you are seeking a reliable Diphenoxylate Hydrochloride and Atropine Sulphate Tablets 2.5mg+0.025mg Manufacturer Supplier in India, Taj Pharma is your trusted partner for quality, compliance, and global reach.

👉 Contact Taj Pharma today for export inquiries, pricing, dossiers, samples, or PCD Pharma Franchise opportunities.

Top 20 FAQs

1. What is this medicine used for?
   It treats moderate to severe diarrhea in adults.

2. Is Taj Pharma WHO-GMP certified?
   Yes, Taj Pharma is a WHO-GMP certified manufacturer.

3. Can it be exported from India?
   Yes, with complete regulatory documentation.

4. What is the shelf life?
   36 months.

5. Is custom labeling available?
   Yes, buyer-specific labeling is supported.

6. What packaging options exist?
   Blister, Alu-Alu, and bottle packs.

7. Is it safe for children?
   Contraindicated for children under six years.

8. Does Taj Pharma provide COPP?
   Yes.

9. Is it prescription-only?
   Yes.

10. What are common side effects?
    Dry mouth, dizziness, constipation.

11. Does Taj Pharma assist with registration?
    Yes, via CTD dossiers.

12. Can it be used long-term?
    Only under medical supervision.

13. Is Mumbai supply available?
    Yes.

14. Does Taj Pharma offer PCD franchise?
    Yes.

15. Which countries does Taj Pharma export to?
    Over 20 countries worldwide.

16. Does it cause drowsiness?
    It may in some patients.

17. What storage is required?
    Below 25°C, dry place.

18. Is bulk supply available?
    Yes.

19. Is it abuse-deterrent?
    Atropine is added to prevent abuse.

20. How to contact Taj Pharma?
    Via official website or export inquiry channels.