Roxatidine tablets 40mg

Roxatidine tablets 40mg Tablets Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Roxatidine tablets 20mg Tablets
• Roxatidine tablets 40mg Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Roxatidine tablets 20mg Tablets
  Roxatidine ……..20 mg
  Excipients…………..q.s.
• Roxatidine tablets 40mg Tablets
  Roxatidine ……..40 mg
  Excipients…………..q.s.

THERAPEUTIC INDICATIONS:

Roxatidine is a histamine H2 receptor antagonist. It works by reducing the acid produced in the stomach which helps in relief of acid-related indigestion and heartburn.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage:  Protect from moisture at a temperature not exceeding 30˚C.
Do not freeze.
Protect from light. store in a cool, dry place.
Dosage:  As directed by the Physician.

Roxatidine Tablets 40mg Manufacturer in India

Taj Pharma Ltd is an established Indian pharmaceutical company offering pharmaceutical manufacturing, supply, and export solutions for international buyers. The company serves pharmaceutical importers, distributors, wholesalers, marketing companies, and healthcare businesses seeking quality pharmaceutical products from India.

For buyers searching for a Roxatidine Tablets 40mg Manufacturer in India, Taj Pharma can provide product and export information covering specifications, packaging, documentation, commercial requirements, and international supply, subject to product availability and the regulatory requirements of the destination market.

Roxatidine Tablets 40mg contain Roxatidine, an H2-receptor antagonist that reduces gastric acid secretion. Roxatidine may be used in the management of acid-related gastrointestinal conditions, including gastroesophageal reflux disease (GERD), heartburn, acid-related dyspepsia, and peptic ulcer disease, according to applicable prescribing information.

Introduction to Roxatidine Tablets 40mg

Roxatidine is a pharmaceutical active ingredient belonging to the histamine H2-receptor antagonist class. It works by blocking H2 receptors involved in gastric acid secretion, thereby reducing the amount of acid produced by the stomach. Reduction of gastric acid can help manage symptoms and conditions associated with excessive gastric acidity.

Roxatidine Tablets 40mg are an oral solid dosage form designed for administration according to the prescribing instructions applicable to the product and destination market. The medicine may be prescribed for acid-related gastrointestinal disorders, depending on the patient’s condition and local approved indications.

Key product points

• Product: Roxatidine Tablets 40mg
• Active Ingredient: Roxatidine
• Strength: 40mg
• Dosage Form: Tablet
• Route: Oral
• Therapeutic Category: H2-receptor antagonist
• Primary Action: Reduction of gastric acid secretion
• Potential Uses: GERD, acid reflux, heartburn, acid-related dyspepsia and peptic ulcer disease, where approved
• Country of Manufacture: India
• Supply: Domestic and international, subject to availability and applicable regulations

The international pharmaceutical market continues to require medicines for the management of gastrointestinal and acid-related disorders. This creates opportunities for pharmaceutical importers and distributors seeking reliable sources of established gastrointestinal products.

For companies looking for a Roxatidine Tablets 40mg Supplier in India, supplier selection should consider manufacturing capability, quality systems, regulatory documentation, packaging flexibility, export experience, and consistency of supply.

Roxatidine Tablets 40mg Manufacturer, Supplier and Exporter in India

Taj Pharma Ltd supports pharmaceutical buyers seeking products manufactured and supplied from India. International buyers can discuss their requirements directly with the company to determine product availability, specifications, packaging, documentation, pricing, and shipment arrangements.

As an Roxatidine Tablets 40mg Manufacturer and Exporter in India, Taj Pharma can work with buyers according to their intended market and procurement requirements.

Taj Pharma can discuss requirements related to:

• Bulk pharmaceutical supply
• Distributor and importer requirements
• Market-specific packaging
• Product labeling
• Export documentation
• Technical product information
• Quality documentation
• Commercial quotations
• Shipment coordination
• Destination-country requirements

The exact product presentation, manufacturing arrangement, documentation, and availability should always be confirmed directly with Taj Pharma before placing a purchase order.

Information for Pharmaceutical Importers, Exporters and Buyers

International pharmaceutical procurement requires careful coordination between the manufacturer, importer, distributor, regulatory authority, and logistics provider. Buyers of Roxatidine Tablets 40mg may require a combination of commercial, technical, quality, and regulatory documentation.

Taj Pharma can discuss the documentation package required for the proposed destination market and supply arrangement.

Regulatory Documentation

Depending on the country of import and the registration pathway, pharmaceutical buyers may require several documents supporting the product and manufacturing process.

Possible documentation may include:

• Certificate of Analysis (CoA)
• Product specifications
• Finished-product specifications
• Manufacturing information
• Stability information, where applicable
• Packaging specifications
• Certificate of Origin
• GMP-related documentation
• Certificate of Pharmaceutical Product (CPP/COPP), where applicable
• Free Sale documentation, where applicable
• Batch-related quality documents
• Technical documentation
• CTD-format regulatory information, where applicable

The precise documentation requirements differ between countries. Therefore, importers should provide Taj Pharma with their destination country and regulatory requirements so the available documentation can be assessed accordingly.

Custom Packaging and Labeling

Pharmaceutical distributors frequently require packaging designed for a specific market. Taj Pharma can discuss customized packaging requirements according to the product, order volume, destination-country regulations, and approved artwork.

Depending on the commercial arrangement, packaging discussions may include:

• Blister packaging
• Carton configuration
• Pack size
• Product artwork
• Brand name
• Generic name
• Language requirements
• Batch number
• Manufacturing date
• Expiry date
• Storage instructions
• Manufacturer details
• Regulatory statements
• Market-specific labeling requirements

All pharmaceutical artwork and labeling should be reviewed according to the regulations applicable to the intended market before commercial production.

Shelf Life, Storage and Dosage Form

Roxatidine Tablets 40mg are supplied as an oral tablet dosage form. The applicable shelf life should be confirmed from the current approved product specifications and batch documentation.

Product handling considerations

• Dosage form: Oral tablet
• Strength: 40mg
• Storage: Follow the approved product label
• Shelf life: As specified in the approved product documentation
• Packaging: Subject to the agreed commercial presentation
• Transportation: Maintain appropriate pharmaceutical storage and transportation conditions

Importers and distributors should ensure that pharmaceutical products remain within the manufacturer’s specified storage conditions throughout transportation, warehousing, and distribution.

Export Certifications and Regulatory Support

Pharmaceutical importers may require different certificates depending on the destination country. Documents such as WHO-GMP-related documentation, EU-GMP documentation, CPP/COPP, CTD dossiers, Certificates of Analysis, Certificates of Origin, and other regulatory documents may be relevant to particular markets.

However, certification requirements are product- and market-specific. Buyers should verify the exact status and availability of each certificate with Taj Pharma before making regulatory or commercial commitments.

Commonly requested pharmaceutical export documents may include:

1. Certificate of Analysis
2. GMP Certificate or GMP-related evidence
3. Certificate of Pharmaceutical Product (CPP/COPP), where applicable
4. Certificate of Origin
5. Product specification
6. Stability data
7. Manufacturing information
8. Packaging information
9. Technical dossier
10. CTD documentation, where applicable
11. Batch documentation
12. Other documents requested by the importing authority

For markets requiring specific regulatory certifications, Taj Pharma can evaluate the buyer’s requirements and advise on the documentation available for the relevant product.

Target Countries and International Export Markets

India is an important pharmaceutical manufacturing and export hub, supplying medicines to numerous international markets. Taj Pharma states that it has an international presence with pharmaceutical products exported to 20 countries.

Potential pharmaceutical export destinations can include markets across:

• Africa
• Asia
• Middle East
• Latin America
• Other international pharmaceutical markets

The actual ability to supply Roxatidine Tablets 40mg to a particular country depends on product registration, import regulations, local licensing, intellectual-property considerations, product availability, and other applicable requirements.

For international buyers, providing the destination country at the inquiry stage is important because the required documentation, packaging, labeling, registration, and import procedures may vary significantly from one market to another.

Why Choose Taj Pharma for Roxatidine Tablets 40mg?

Choosing a pharmaceutical supplier requires consideration of quality, manufacturing capabilities, commercial competitiveness, documentation, and international supply support. Taj Pharma provides pharmaceutical sourcing and export solutions for buyers seeking products from India.

Pharmaceutical Manufacturing Experience

Taj Pharma operates in the pharmaceutical sector and supports customers seeking pharmaceutical products for domestic and international markets. Buyers can discuss their specific requirements with the company to determine the appropriate product and supply arrangement.

Focus on Quality and Consistency

Quality assurance is an important part of pharmaceutical manufacturing. Product specifications, quality-control procedures, testing, and batch documentation form an important part of pharmaceutical supply.

For buyers, the relevant quality documentation should be confirmed for the particular product, manufacturing arrangement, and destination market.

Competitive Pharmaceutical Pricing

India’s established pharmaceutical manufacturing ecosystem enables international buyers to explore competitive pharmaceutical sourcing options.

Taj Pharma can provide quotations based on factors such as:

• Order quantity
• Packaging requirements
• Destination country
• Product presentation
• Regulatory requirements
• Shipping arrangements
• Documentation requirements

For this reason, buyers should request a current quotation based on their actual requirements.

International Supply Support

International pharmaceutical supply involves more than manufacturing. Importers also need coordination involving packaging, documentation, logistics, freight, and destination-country requirements.

Taj Pharma supports international buyers by discussing these requirements during the procurement process.

Exporting to 20 Countries

Taj Pharma states that it exports pharmaceutical products to 20 countries, reflecting its international business orientation and experience in serving overseas pharmaceutical buyers.

International buyers can contact the company to determine whether Roxatidine Tablets 40mg are currently available for their market and whether the required export documentation can be provided.

Technical Product Specifications

How Does Roxatidine Work?

Roxatidine is an H2-receptor antagonist. Histamine interacts with H2 receptors in the stomach and stimulates gastric acid secretion. Roxatidine blocks these receptors and therefore reduces acid production.

Lower gastric acid levels can help reduce acid-related symptoms and support the management of certain gastrointestinal conditions.

Roxatidine may be used for conditions such as:

• Gastroesophageal reflux disease (GERD)
• Acid reflux
• Heartburn
• Acid-related dyspepsia
• Peptic ulcer disease
• Other acid-related conditions where clinically indicated

The appropriate indication and dosage should be determined using the applicable approved prescribing information and advice from a qualified healthcare professional.

How to Take Roxatidine Tablets 40mg

Roxatidine should be taken exactly as directed by a doctor or according to the approved prescribing information.

Depending on the prescribed regimen, Roxatidine may be taken with or without food. When prescribed once daily, the timing may be specified by the healthcare professional, and some regimens use bedtime administration.

Patients should:

• Follow the prescribed dose.
• Take the tablet as directed.
• Avoid changing the dose without medical advice.
• Inform their doctor about other medicines they are taking.
• Inform their doctor about kidney or liver problems.
• Avoid stopping long-term prescribed treatment without professional advice.

If an antacid or another acidity medicine is being used, patients should ask their doctor or pharmacist about appropriate timing and potential interactions rather than automatically following a fixed interval.

Possible Side Effects of Roxatidine

Like all medicines, Roxatidine can potentially cause side effects. Many adverse effects may be mild, but persistent, severe, or unusual symptoms should be evaluated by a healthcare professional.

Reported or potentially associated reactions may include:

• Gastrointestinal disturbances
• Sleep disturbance
• Restlessness
• Changes in pulse rate
• Changes in liver enzymes
• Reduced sexual desire
• Hair loss
• Breast enlargement in males
• Changes in blood-cell counts
• Low platelet count
• Reduced white blood-cell count
• Pancreatic inflammation in rare circumstances

Patients experiencing serious or persistent symptoms should seek medical advice promptly.

Important Precautions

Patients should inform their healthcare professional before using Roxatidine if they have a history of significant medical conditions, particularly kidney or liver problems.

Medical advice is especially important when symptoms are persistent or accompanied by warning signs such as:

• Difficulty swallowing
• Unexplained weight loss
• Persistent vomiting
• Gastrointestinal bleeding
• Severe abdominal pain
• Persistent symptoms despite treatment

Patients should not use pharmaceutical information on this page as a substitute for professional medical advice or the approved prescribing information.

Roxatidine Tablets 40mg Export from India

For international pharmaceutical companies searching for Roxatidine Tablets 40mg export from India, Taj Pharma can be contacted to discuss the intended market and supply requirements.

A typical export inquiry should include:

1. Destination country
2. Required quantity
3. Preferred dosage and pack size
4. Packaging requirements
5. Required certificates
6. Registration requirements
7. Target delivery schedule
8. Buyer/importer details where required
9. Any special labeling requirements

Providing these details allows the supplier to assess the inquiry more efficiently and determine the appropriate commercial and regulatory pathway.

Pharmaceutical Buyer and Distributor Support

Taj Pharma can work with pharmaceutical importers and distributors who require a structured supply arrangement.

Buyers can discuss:

• Product availability
• MOQ requirements
• Pricing
• Packaging
• Private-label requirements, where applicable
• Regulatory documentation
• Export certificates
• Shipping arrangements
• Batch documentation
• Destination-country requirements

The availability of particular certifications, presentations, or packaging configurations should be confirmed directly before ordering.

Contact Taj Pharma

Mobile / WhatsApp Support:
+91-74-0000-9975
+91-74-0000-9976

Email: info@tajpharma.com
tajgroup@tajpharma.com

Taj Pharma Ltd welcomes inquiries from pharmaceutical importers, distributors, wholesalers, and international buyers interested in Roxatidine Tablets 40mg manufacturing and supply from India.

Top 20 FAQs

1. What are Roxatidine Tablets 40mg?

Roxatidine Tablets 40mg are an oral pharmaceutical formulation containing 40mg of Roxatidine. Roxatidine is an H2-receptor antagonist that reduces gastric acid secretion.

2. What is Roxatidine used for?

Roxatidine may be used for the management of acid-related gastrointestinal conditions, including GERD, acid reflux, heartburn, dyspepsia, and peptic ulcer disease, depending on the approved indication in the relevant market.

3. How does Roxatidine work?

Roxatidine blocks histamine H2 receptors in the stomach, reducing gastric acid secretion.

4. Is Roxatidine an H2-receptor antagonist?

Yes. Roxatidine belongs to the histamine H2-receptor antagonist class of medicines.

5. What is the strength of the product?

The product discussed here is Roxatidine Tablets 40mg, containing 40mg of Roxatidine per tablet.

6. Is Taj Pharma a Roxatidine Tablets 40mg manufacturer in India?

Taj Pharma Ltd is an Indian pharmaceutical company offering manufacturing, supply, and export services. Buyers should contact the company directly to confirm the current manufacturing and supply arrangement for Roxatidine Tablets 40mg.

7. Can Taj Pharma export Roxatidine Tablets 40mg?

Export availability depends on product availability, destination-country regulations, registration requirements, and commercial conditions. International buyers can contact Taj Pharma for current export information.

8. Can buyers request customized packaging?

Customized packaging may be discussed depending on the product, order quantity, market requirements, artwork, and applicable regulations.

9. What packaging options are available?

Packaging may include blister packs and cartons, subject to the product presentation and buyer requirements. The final configuration should be confirmed with Taj Pharma.

10. What regulatory documents are available?

Depending on the market and supply arrangement, buyers may request CoA, GMP-related documentation, CPP/COPP where applicable, Certificate of Origin, product specifications, stability information, and technical documentation.

11. Can Taj Pharma provide CTD documentation?

CTD-format technical documentation may be relevant to certain registration procedures. Buyers should contact Taj Pharma with their destination-country requirements to confirm the documentation available for the relevant product.

12. What is the shelf life of Roxatidine Tablets 40mg?

The applicable shelf life should be confirmed from the current approved product documentation and packaging for the relevant product batch.

13. How should Roxatidine Tablets 40mg be stored?

The product should be stored according to the approved manufacturer’s storage instructions and product label. Proper pharmaceutical storage conditions should be maintained throughout the supply chain.

14. Can Roxatidine be taken with food?

Depending on the approved prescribing information, Roxatidine may be taken with or without food. Patients should follow the instructions provided by their healthcare professional.

15. Should Roxatidine be taken at bedtime?

Some once-daily regimens may specify bedtime administration. However, the correct timing depends on the indication and prescribing instructions. Patients should follow their doctor’s directions.

16. What are the possible side effects of Roxatidine?

Possible adverse effects can include gastrointestinal disturbances, sleep disturbance, restlessness, changes in pulse rate, changes in liver enzymes, and blood-count abnormalities, among others.

17. Can people with kidney disease take Roxatidine?

Patients with kidney disease should inform their doctor before using Roxatidine because renal function may affect treatment considerations and dosing.

18. How can I obtain the price of Roxatidine Tablets 40mg?

Contact Taj Pharma with your required quantity, destination country, packaging preference, and documentation requirements for a current commercial quotation.

19. Does Taj Pharma supply pharmaceutical products internationally?

Taj Pharma states that it exports pharmaceutical products to 20 countries. International buyers should contact the company to confirm current product availability and destination-specific export requirements.

20. How can I contact Taj Pharma for Roxatidine Tablets 40mg?

Buyers can contact Taj Pharma through info@tajpharma.com, tajgroup@tajpharma.com, telephone, or WhatsApp using the contact information provided above.