Diphenoxylate Hydrochloride & Atropine Sulphate Tablets IP (2.5mg+0.025mg)

Diphenoxylate Hydrochloride & Atropine Sulphate Tablets IP (2.5mg+0.025mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Diphenoxylate Hydrochloride & Atropine Sulphate Tablets IP

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Diphenoxylate Hydrochloride & Atropine Sulphate Tablets IP
  Each uncoated tablet contains:
  Diphenoxylate Hydrochloride IP…………………2.5mg
  Atropine Sulphate IP………………………………0.025mg
  Excipients……………………………………………q.s

THERAPEUTIC INDICATIONS:

Diphenoxylate and atropine combination is used along with other measures (fluid and electrolyte treatment) to treat severe diarrhea. Diphenoxylate helps stop diarrhea by slowing down the movements of the intestines.

CAUTION & SCHEDULE:

CAUTION:  Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablets to be swallowed as a whole, and not to be chewed or crushed.

SCHEDULE H1 PRESCRIPTION DRUG-CAUTION:
-It is dangerous to take this preparation except in accordance with the medical advice.
-Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.

Dosage: As directed by the physician.

Diphenoxylate Hydrochloride & Atropine Sulphate Tablets Manufacturer Supplier in India

Looking for a Diphenoxylate Hydrochloride & Atropine Sulphate Tablets Manufacturer in India? Taj Pharma offers WHO-GMP certified, export-quality products with global documentation and supply capabilities. If you are searching for a trusted, experienced, and globally certified Diphenoxylate Hydrochloride & Atropine Sulphate Tablets Manufacturer in India, look no further than Taj Pharma. Renowned for its exceptional manufacturing standards, Taj Pharma is a WHO-GMP, ISO 9001:2018, and PIC/S certified pharmaceutical company headquartered in Vapi, Gujarat, India. With decades of industry experience, Taj Pharma is at the forefront of producing high-quality Diphenoxylate Hydrochloride 2.5 mg + Atropine Sulphate 0.025 mg Tablets, meeting stringent international regulatory standards.

Diphenoxylate Hydrochloride & Atropine Sulphate Tablets are widely used in the treatment of acute and chronic diarrhea, especially when non-infectious causes are suspected. The combination works synergistically to reduce bowel movements and increase fluid absorption, providing fast and effective relief. Taj Pharma manufactures these tablets in state-of-the-art, GMP-compliant facilities, ensuring consistency, safety, and efficacy in every batch.

As a leading supplier and exporter, Taj Pharma provides end-to-end services including:

• Comprehensive regulatory documentation: CTD Dossiers, WHO-GMP, CoPP, FSC, and more.

• Flexible packaging solutions: blister packs, bottles, strips, with multilingual inserts.

• Global reach: Exporting to over 40 countries in Africa, LATAM, Middle East, Southeast Asia, and CIS.

• Support for product registration and custom labeling as per importing country requirements.

• Contract manufacturing, third-party labeling, and PCD Pharma franchise models.

Whether you’re a hospital supplier, tender participant, distributor, or pharmaceutical agent, Taj Pharma ensures a reliable supply chain, competitive pricing, and timely delivery. With a strong presence across regulated and semi-regulated markets, Taj Pharma is the preferred choice for buyers worldwide looking for a dependable Diphenoxylate Hydrochloride & Atropine Sulphate Tablets supplier from India.

Diphenoxylate Hydrochloride & Atropine Sulphate Tablets

Diphenoxylate Hydrochloride & Atropine Sulphate Tablets are a widely used combination medication for the treatment of acute diarrhea. This combination slows bowel movements, allowing the body to absorb more fluid and electrolytes. It’s prescribed for patients suffering from chronic or traveler’s diarrhea, especially when non-infectious causes are suspected.

At the global level, these tablets are in steady demand due to their essential role in gastrointestinal therapy, particularly in tropical and developing regions. With increasing instances of waterborne diseases, the demand for Diphenoxylate Hydrochloride & Atropine Sulphate Tablets has surged in Asia, Africa, LATAM, and the Middle East.

Taj Pharma India Ltd is a globally recognized pharmaceutical manufacturer and exporter, specializing in Diphenoxylate Hydrochloride & Atropine Sulphate Tablets, an essential medication for the treatment of acute and chronic diarrhea. These tablets are in consistent demand across international markets due to their proven efficacy in gastrointestinal therapy, particularly in regions dealing with waterborne illnesses and non-infectious diarrhea.

Manufactured at Taj Pharma’s WHO-GMP certified facility in Vapi, Gujarat, the product is produced under strict quality control and international regulatory standards. The tablets combine Diphenoxylate, which reduces bowel movement frequency, and Atropine, which prevents misuse, making it a safe and effective solution for both short-term and long-term use. Taj Pharma ensures each batch adheres to pharmacopeial standards and offers packaging customization, multilingual inserts, and long shelf life, catering to market-specific requirements.

As a leading Diphenoxylate Hydrochloride & Atropine Sulphate Tablets Manufacturer in India, Taj Pharma provides comprehensive regulatory documentation, including CTD dossiers, CoPPs, and Free Sale Certificates, facilitating smooth product registration for importers. The company’s strong logistics support ensures timely exports to over 40 countries, including top markets like Iraq, Nigeria, Kenya, Egypt, Philippines, Vietnam, Saudi Arabia, South Africa, and the UAE.

What sets Taj Pharma apart is its combination of affordable pricing, high-quality assurance, scalable production, and a global distribution network. The company welcomes government tenders, hospital procurement agents, and private distributors to partner for exclusive territory rights, with full marketing and technical support.

For international buyers seeking a reliable, certified, and quality-driven pharmaceutical exporter, Taj Pharma stands out as the preferred partner for Diphenoxylate Hydrochloride & Atropine Sulphate Tablets. With a reputation built on compliance, integrity, and global reach, Taj Pharma is the go-to choice for sourcing this essential medicine from India.

Global Demand and Applications

Diphenoxylate Hydrochloride (an opioid receptor agonist) works directly on intestinal muscles, while Atropine (an anticholinergic) is added to discourage abuse. The product is vital for managing symptoms of acute and chronic diarrhea, especially when rehydration therapy alone is insufficient.

Common applications include:

• Treatment of acute non-specific diarrhea

• Management of irritable bowel syndrome

• Supportive therapy for gastroenteritis

• In palliative care, to control bowel frequency

The pharmaceutical export market shows consistent demand in:

• Africa

• Middle East

• Southeast Asia

• Latin America

• Eastern Europe

Key Regulatory and Export Support for Importers/Buyers

Taj Pharma, a WHO-GMP certified Diphenoxylate Hydrochloride & Atropine Sulphate Tablets Manufacturer in India, ensures regulatory compliance and support across global markets.

✅ Regulatory Documentation Offered

• Certificate of Pharmaceutical Product (CoPP)

• WHO-GMP, ISO 9001:2015 certifications

• CTD Dossiers, Site Master File (SMF)

• Stability data (ICH guidelines)

• Free Sale Certificates

• Product Registration Support

✅ Packaging and Labeling

• Custom branded packaging

• Multilingual inserts (as per buyer needs)

• Blister, strip, or bottle formats available

• Export-friendly outer cartons

• Tamper-proof, barcoded packaging

✅ Shelf Life and Dosage Form

• Available as oral tablets

• Dosage: Diphenoxylate Hydrochloride 2.5 mg + Atropine Sulphate 0.025 mg

• Shelf life: 24 to 36 months

• Storage: Below 30°C, away from moisture and light

✅ Export Markets & Compliance

Taj Pharma exports to over 42 countries, including:

Taj Pharma has a strong international presence, exporting to over 42 countries across the globe. Key export markets include Nigeria, Iraq, Yemen, Vietnam, the Philippines, Myanmar, Kazakhstan, South Africa, Ethiopia, Sri Lanka, Panama, and Kuwait. The company ensures full compliance with international regulatory standards, making it a trusted partner for pharmaceutical exports worldwide.

Most Trusted Manufacturer, Supplier & Exporter

Taj Pharma India Ltd is among the Top 10 Diphenoxylate Hydrochloride & Atropine Sulphate Tablets Manufacturers in India and holds a strong reputation for quality and global presence.

1. World-Class Manufacturing Infrastructure

Located in Vapi, Gujarat, Taj Pharma’s manufacturing plant is WHO-GMP, GLP, and ISO 9001:2018 certified, adhering to international regulatory norms.

2. Affordable Pricing with Premium Quality

Taj Pharma provides competitive pricing, bulk order options, and contract manufacturing with full batch control, meeting the highest pharmacopoeial standards.

3. Extensive Global Supply Chain

With partners in Africa, Middle East, LATAM, and CIS regions, Taj Pharma ensures:

• Fast shipping

• Low Minimum Order Quantities (MOQ)

• Flexible logistics

• Cold chain & ambient temperature delivery

Top 20 Countries Exported To:

Taj Pharma proudly exports Diphenoxylate Hydrochloride & Atropine Sulphate Tablets to more than 40 countries worldwide, with strong demand in key markets. The top 20 countries where our products are regularly supplied include Iraq, Nigeria, Kenya, Egypt, Vietnam, Sri Lanka, Philippines, Panama, Tanzania, Ethiopia, DR Congo, Myanmar, Kazakhstan, Yemen, Sudan, Ghana, Uzbekistan, Saudi Arabia, UAE, and South Africa. These nations represent our extensive global footprint and highlight Taj Pharma’s reputation as a trusted pharmaceutical exporter across Asia, Africa, the Middle East, and beyond.

Technical Product Specification

Call to Action: Become a Global Distributor of Taj Pharma Today

Are you an importer, hospital tender supplier, pharma distributor, or government procurement agency looking for a reliable Diphenoxylate Hydrochloride & Atropine Sulphate Tablets Manufacturer in India?

Taj Pharma India Ltd invites strategic alliances, distribution partnerships, and long-term export collaborations. We offer:

• Fast registration support

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Phone: +91 84484 44095 | WhatsApp: +91 7400009975 / +91 7400009976
Email: info@tajpharma.com
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Top 20 FAQs: Diphenoxylate Hydrochloride & Atropine Sulphate Tablets

1. What are Diphenoxylate Hydrochloride & Atropine Sulphate Tablets used for?

Primarily used to treat acute diarrhea in adults.

2. How does this medication work?

It slows bowel movements and helps absorb more water, reducing diarrhea.

3. Can it be given to children?

Only under strict supervision and not recommended for children under 6.

4. What is the recommended adult dosage?

Usually, 2 tablets four times daily. Maintenance dose may vary.

5. Is Taj Pharma a WHO-GMP certified manufacturer?

Yes, fully certified and inspected.

6. Can Taj Pharma assist with product registration?

Yes, full regulatory support including CTD dossiers.

7. What packaging options are available?

Blister packs, strips, bottles with custom branding and labeling.

8. What is the shelf life of the product?

24 to 36 months depending on storage conditions.

9. Are the tablets suitable for export to regulated markets?

Yes, with CTD, CoPP, and all required documentation.

10. Do you offer contract manufacturing?

Yes, including third-party and private label manufacturing.

11. Is shipping available globally?

Yes, Taj Pharma exports to 40+ countries.

12. Is cold chain shipping required?

No, standard ambient shipping is sufficient.

13. Are there any side effects?

Possible drowsiness, dry mouth, dizziness. Rarely serious effects.

14. Is the product available in stock?

Yes, commonly stocked for fast dispatch.

15. Can Taj Pharma supply to government tenders?

Yes, already a preferred supplier for many ministries.

16. Do you offer promotional support?

Yes, for bulk buyers and long-term partners.

17. What is the production capacity?

Millions of tablets monthly; scalable on demand.

18. What are the storage conditions?

Keep below 30°C, dry area, away from sunlight.

19. Can I request a sample?

Yes, for evaluation after basic formalities.

20. Is Taj Pharma open for distribution partnerships?

Absolutely, inquiries are welcome worldwide.

Taj Pharma stands tall as the leading Diphenoxylate Hydrochloride & Atropine Sulphate Tablets Manufacturer in India, offering unmatched quality, documentation, pricing, and global reach. Whether you are an importer, government buyer, or hospital tender agent, Taj Pharma is your most reliable source for this essential anti-diarrheal medication.

Take advantage of our WHO-GMP certified infrastructure, experienced regulatory team, and PAN India & global supply capability.

Product Technical Data Sheet (TDS)

Product Name:  Diphenoxylate Hydrochloride 2.5 mg + Atropine Sulphate 0.025 mg Tablets

Brand Name:  Lomotil (International Reference Brand)

Category: Antidiarrheal

Dosage Form: Film-coated Tablet (Oral administration)

Strength

• Diphenoxylate Hydrochloride 2.5 mg

• Atropine Sulphate 0.025 mg

Packing

• Blister pack of 10 tablets, 20 tablets, or as per regulatory requirement.

• Bulk packs available for institutional/ hospital supply.

Description

Diphenoxylate Hydrochloride is a synthetic opioid derivative that exerts an antidiarrheal effect by slowing gastrointestinal motility. It is structurally related to meperidine.
Atropine Sulphate, an anticholinergic, is included in subtherapeutic doses to discourage deliberate misuse or overdose due to diphenoxylate’s opioid-like effects.

Appearance: White or almost white, round, film-coated tablets.

Pharmacological Classification

• Therapeutic Class: Antidiarrheals, Opioid agonists

• ATC Code: A07DA01

Mechanism of Action (Pharmacodynamics)

• Diphenoxylate HCl: Acts primarily on the smooth muscle of the intestines, reducing motility by binding to opioid receptors. This results in prolonged transit time of intestinal contents and increased absorption of fluid and electrolytes.

• Atropine Sulphate: Added in minimal concentration to reduce the risk of abuse. At higher doses, atropine causes unpleasant anticholinergic effects (dry mouth, blurred vision, tachycardia), which deter overconsumption.

Indications

Diphenoxylate HCl + Atropine Sulphate Tablets are indicated for:

• Symptomatic treatment of acute diarrhea (non-infectious).

• Chronic diarrhea in certain conditions (as adjunctive therapy).

• Decreasing frequency and liquidity of bowel movements.

• Control of diarrhea associated with irritable bowel syndrome (IBS).

⚠️ Not effective in diarrhea caused by invasive organisms (e.g., Clostridium difficile, Salmonella, Shigella).

Dosage & Administration

Adults:

• Initial dose: 2 tablets (5 mg Diphenoxylate HCl) four times daily (max 20 mg/day).

• Maintenance dose: Once diarrhea is controlled, dosage should be reduced to the minimum effective dose (usually 2 tablets/day).

Geriatric: Dose adjustments may be required due to increased sensitivity to CNS and anticholinergic effects.

Pediatric:

• Contraindicated in children under 6 years due to risk of respiratory and CNS depression.

• Use in children above 13 years with extreme caution (not routinely recommended).

Administration Route: Oral. Tablets should be swallowed whole with water.

Contraindications

• Hypersensitivity to diphenoxylate, atropine, or any excipients.

• Children <6 years (due to risk of severe respiratory depression).

• Jaundice, obstructive jaundice.

• Infectious diarrhea (caused by invasive bacteria).

• Pseudomembranous colitis associated with broad-spectrum antibiotic use.

• Severe dehydration and electrolyte imbalance (treat first before initiating).

Side Effects / Adverse Reactions

Common

• Drowsiness, dizziness, headache

• Dry mouth, blurred vision

• Constipation, nausea, vomiting

• Abdominal pain, bloating

Uncommon to Rare

• Respiratory depression (at higher doses/overdose)

• CNS effects: euphoria, hallucinations, depression

• Allergic reactions: rash, urticaria, angioedema

• Tachycardia, palpitations

• Paralytic ileus (rare, severe)

Overdose Risks

• Respiratory depression (especially in children)

• CNS depression → coma

• Anticholinergic toxicity (due to atropine)
  Treatment: Naloxone (opioid antagonist) for diphenoxylate toxicity, plus supportive measures.

Drug Interactions

• CNS depressants (alcohol, sedatives, hypnotics, tranquilizers) → additive CNS depression.

• MAO inhibitors → risk of hypertensive crisis, severe adverse reactions.

• Other anticholinergics (tricyclic antidepressants, antihistamines, antipsychotics) → increased atropine toxicity.

Precautions

• Caution in elderly patients (risk of confusion, sedation).

• Avoid in hepatic impairment → risk of hepatic encephalopathy.

• Monitor in renal impairment.

• Not recommended during pregnancy unless necessary.

• Lactation: Excreted in breast milk; not recommended.

• Not suitable for diarrhea caused by bacterial infections (risk of worsening).

• Patients should maintain adequate hydration and electrolyte replacement.

Benefits

• Effective antidiarrheal in non-infectious diarrhea.

• Convenient oral administration.

• Rapid relief from frequent loose stools.

• Helps improve quality of life in chronic diarrhea patients.

• Combination formulation discourages misuse/abuse.

Storage Conditions

• Store below 25°C, in a dry place.

• Protect from light and moisture.

• Keep out of reach of children.

• Do not use after expiry date.

Regulatory & Quality Compliance

• Pharmacopoeial Standard: As per USP / BP / IP monographs.

• Regulatory Status: WHO essential medicines list (Diphenoxylate + Atropine).

• Manufacturing Compliance: WHO-GMP, PIC/S, ISO certified facility.

GENERIC NAME OF THE MEDICINAL PRODUCT

Diphenoxylate Hydrochloride + Atropine Sulphate Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

• Diphenoxylate Hydrochloride IP/USP/BP ……………… 2.5 mg

• Atropine Sulphate IP/USP/BP ……………………………… 0.025 mg

• Excipients …………………………………………………… q.s.

CAUTION & WARNING

• Schedule H Drug (Prescription Only).

• Not recommended for pediatric patients under 6 years.

• Risk of opioid-like dependence if misused.

• Avoid use in infectious diarrhea – may cause worsening of condition.

STORAGE & DOSAGE

• Store below 25°C, dry and dark place.

• Usual adult dose: 2 tablets initially, followed by 1 tablet after each loose stool (max 8 tablets/day).

• Discontinue once diarrhea is controlled.