Dapagliflozin Tablet 10mg

Dapagliflozin Tablet 10mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Dapagliflozin Tablet 5mg
• Dapagliflozin Tablet 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Dapagliflozin Tablet 5mg
  Each filmed coated Tablet contains:
  Dapagliflozin propanediol monohydrate
  Equivalent to Dapagliflozin…………………………5mg
  Excipients……………………………………………………q.s.
  Colours: Iron oxide Yellow
• b) Dapagliflozin Tablet 10mg
  Each filmed coated Tablet contains:
  Dapagliflozin propanediol monohydrate
  Equivalent to Dapagliflozin…………………………10mg
  Excipients……………………………………………………q.s.
  Colours: Quinoline Yellow

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 Prescriber.
  

STORAGE & DOSAGE:

• Storage: Protect form moisture at a temperature not exceeding 25˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
• Dosage: As directed by the Physician.

Dapagliflozin Tablet 10 mg – Detailed Patient Information

What is Dapagliflozin?

Dapagliflozin is a prescription medicine used to help control blood sugar levels in people with type 2 diabetes mellitus. It belongs to a class of drugs called SGLT2 inhibitors (Sodium-Glucose Co-Transporter-2 inhibitors). It works by helping your kidneys remove excess sugar (glucose) from your blood through urine.

How Does Dapagliflozin Work?

Normally, your kidneys filter sugar from your blood and then reabsorb most of it back into your body. Dapagliflozin blocks the protein (SGLT2) responsible for reabsorbing sugar, so more sugar leaves your body in the urine. This helps lower your blood sugar levels and improves diabetes control.

What is the Strength and Form?

• Dapagliflozin is available in a strength of 10 mg per tablet. It comes in the form of an oral tablet, which is typically white or off-white in color and may be round or oval in shape. The medication is usually packaged in convenient blister packs or bottles, making it easy for patients to take their daily dose as prescribed.

Who Should Take Dapagliflozin?

• Dapagliflozin is intended for use by adults who have been diagnosed with type 2 diabetes. It can be prescribed as a standalone treatment or in combination with other diabetes medications, such as metformin or insulin, to help achieve better control of blood sugar levels. In addition to managing diabetes, Dapagliflozin is sometimes recommended to reduce the risk of complications like heart failure or kidney problems that are commonly associated with the condition.

How to Take Dapagliflozin?

• Dapagliflozin should be taken as one 10 mg tablet once daily, either with or without food. It is important to swallow the tablet whole with water, without crushing or chewing it. For best results, take the medication at the same time each day to help maintain consistent levels of the drug in your bloodstream. Even if you begin to feel well, do not stop taking Dapagliflozin without first consulting your doctor, as this could affect your blood sugar control and overall treatment plan.

Important Precautions

• Kidney function: Dapagliflozin works through the kidneys, so your doctor may check your kidney function before starting and during treatment.

• Hydration: Because it increases sugar loss through urine, you may urinate more frequently and lose fluids. Drink plenty of water to stay hydrated.

• Low blood sugar risk: When taken with insulin or other diabetes medicines, it may increase the risk of low blood sugar (hypoglycemia). Learn the signs of hypoglycemia (sweating, dizziness, hunger).

• Genital infections: The increased sugar in urine can raise the risk of yeast infections or urinary tract infections. Maintain good hygiene and report symptoms like itching, burning, or pain.

Possible Side Effects

Most people tolerate dapagliflozin well, but some common side effects include:

• Increased urination

• Thirst or dry mouth

• Genital yeast infections (more common in women)

• Urinary tract infections

• Nasopharyngitis (common cold symptoms)

Serious side effects (rare):

• Signs of ketoacidosis (high acids in the blood): nausea, vomiting, stomach pain, tiredness, difficulty breathing — seek immediate medical help.

• Allergic reactions: rash, swelling, difficulty breathing.

Storage Instructions

• Store tablets at room temperature between 20°C to 25°C (68°F to 77°F).

• Keep away from moisture, heat, and direct sunlight.

• Keep out of reach of children.

Drug Interactions

Tell your doctor about all medicines you take, especially:

• Insulin or sulfonylureas (can increase low blood sugar risk)

• Diuretics (“water pills”)

• Blood pressure medications

• Other diabetes medications

Lifestyle Recommendations

• Maintain a balanced diet and exercise regularly as advised by your healthcare provider.

• Monitor your blood sugar levels regularly.

• Avoid excessive alcohol as it may increase side effects.

• Inform your doctor if you plan surgery or become ill; you may need to stop dapagliflozin temporarily.

When to Contact Your Doctor

• Signs of low blood sugar or high blood sugar persist.

• Symptoms of infection (fever, chills, pain during urination).

• Signs of dehydration (dizziness, dry mouth, weakness).

• Any allergic reactions or unusual side effects?

Dapagliflozin 10 mg tablets help lower blood sugar by allowing excess sugar to leave your body through urine. Taking this medication correctly, staying hydrated, and following your doctor’s advice will help manage your diabetes effectively while minimising side effects.

Technical Overview for Contract Manufacturers and Importers: Dapagliflozin Tablet 10 mg

1. Product Overview

Dapagliflozin 10 mg Tablets are oral antihyperglycemic agents belonging to the class of Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors. These tablets are indicated for the treatment of type 2 diabetes mellitus to improve glycemic control, often used as monotherapy or in combination with other antidiabetic agents.

2. Contract Manufacturing Considerations

2.1 Formulation and Composition

• API: Dapagliflozin propanediol monohydrate or anhydrous dapagliflozin, depending on supply.

• Excipients: Selected to ensure stability, bioavailability, and manufacturability, typically including:

  • Fillers (e.g., microcrystalline cellulose, lactose monohydrate)

  • Disintegrants (e.g., croscarmellose sodium)

  • Binders (e.g., povidone)

  • Lubricants (e.g., magnesium stearate)

  • Glidants (e.g., colloidal silicon dioxide)

2.2 Manufacturing Process

• Mixing: Uniform blending of API and excipients under controlled environmental conditions to prevent segregation and ensure content uniformity.

• Granulation: Wet granulation or direct compression method, selected based on flow properties and stability.

• Compression: Use of rotary tablet presses to produce tablets with uniform weight, hardness, and thickness.

• Coating (if applicable): Film coating for improved stability, masking taste, or controlled release.

2.3 Quality Control and Testing

• Content Uniformity: High-performance liquid chromatography (HPLC) method validated for specificity, accuracy, precision, and linearity.

• Dissolution Testing: Conducted in compliance with pharmacopeial standards (USP, EP) to ensure drug release profile meets specifications.

• Stability Testing: Per ICH Q1A guidelines, including accelerated and long-term stability under specified conditions (e.g., 40°C/75% RH).

• Microbial Limits: Ensuring the absence of microbial contamination.

• Physical Parameters: Hardness, friability, disintegration time.

2.4 Packaging and Labelling

• Primary Packaging: Blister packs or HDPE bottles with desiccants to protect against moisture.

• Secondary Packaging: Cartons labelled per regulatory requirement,s including batch number, expiry date, and storage conditions.

• Serialisation and Track & Trace: To meet anti-counterfeiting regulatory requirements.

3. Regulatory Compliance for Contract Manufacturers

• cGMP Compliance: The manufacturing site must comply with current Good Manufacturing Practices (cGMP) guidelines.

• Validation: Process validation, cleaning validation, and analytical method validation must be documented.

• Documentation: Complete Manufacturing Batch Records, Certificates of Analysis (CoA), and Certificate of Compliance (CoC) are mandatory.

• Audit Readiness: Ability to undergo client and regulatory audits.

4. Importer Considerations

4.1 Regulatory Documentation

• Import License: Issued by the competent national regulatory authority (e.g., CDSCO in India, FDA in the US).

• Product Registration: Submission of dossier with Chemistry, Manufacturing, and Controls (CMC) data, bioequivalence studies, and stability data.

• Customs Clearance: Proper documentation for customs, including invoices, CoA, and shipping manifests.

• Cold Chain (if required): Ensuring storage conditions are maintained during transportation.

4.2 Quality Assurance

• Sampling and Testing: Upon receipt, batch samples are tested at accredited laboratories to verify identity, potency, and purity.

• Storage: Warehouses should comply with Good Storage Practices (GSP), ensuring temperature and humidity controls.

• Pharmacovigilance: Systems in place for adverse event reporting post-importation.

5. Supply Chain and Logistics

• Vendor Qualification: Rigorous assessment of contract manufacturers for compliance, capacity, and reliability.

• Batch Traceability: Full traceability of batches from manufacturing through import and distribution.

• Shelf-Life Management: Monitoring expiry dates and rotating stock as per FIFO (First-In-First-Out) practices.

6. Key Technical Challenges

• API Polymorphism and Stability: Ensuring a consistent polymorphic form to avoid bioavailability issues.

• Moisture Sensitivity: Dapagliflozin is hygroscopic; manufacturing and packaging processes must minimize moisture exposure.

• Analytical Challenges: Precise quantification of low-dose API with sensitivity to degradation products.

Successful contract manufacturing and importation of Dapagliflozin 10 mg tablets require stringent process controls, robust quality assurance, and thorough regulatory compliance. Contract manufacturers must ensure cGMP-aligned production with validated processes, while importers must navigate regulatory submissions, documentation, and quality testing to assure product integrity through the supply chain.

⨁ Introduction to Dapagliflozin Tablets 10mg: Medical Purpose and Global Market Relevance

Dapagliflozin Tablet 10mg is a highly effective oral antidiabetic medication primarily used in the management of Type 2 Diabetes Mellitus. It belongs to the class of SGLT2 inhibitors, which function by reducing blood sugar levels through the excretion of glucose in the urine. This medication also shows remarkable cardiovascular and renal benefits, making it a dual-purpose therapeutic option. In recent years, the demand for Dapagliflozin Tablet 10mg has surged globally due to its inclusion in advanced treatment regimens for diabetic patients and those suffering from chronic kidney disease. As a result, international buyers are actively seeking reliable manufacturers and exporters who can guarantee quality, compliance, and consistent supply. Taj Pharma, one of the premier pharmaceutical companies in India, fulfils this demand with unmatched precision and global reputation.

🛡 Comprehensive Documentation and Global Export Readiness for Buyers and Importers

For buyers, importers, and regulatory bodies, Taj Pharma offers an unmatched advantage in terms of compliance and transparency. Each batch of Dapagliflozin Tablet 10mg is accompanied by comprehensive regulatory documentation, including WHO-GMP certification, COPP, CTD/eCTD dossiers, and ICH-stability data. This ensures hassle-free registration and market authorization in various countries. Taj Pharma supports customised export packaging and multilingual labelling based on the importing country’s norms, enabling a smooth transition from port to market shelf. The product is shelf-stable under controlled room temperatures between 20°C and 25°C and comes in high-integrity blister packaging to preserve efficacy throughout its shelf life. In addition to Dapagliflozin Tablet 10mg, the company also offers other high-demand products such as Ivermectin Tablet 6mg, further strengthening its product portfolio for antiviral and chronic therapeutic segments.

🔬 Why Taj Pharma is the Most Trusted Dapagliflozin Tablets 10mg Manufacturer and Global Supplier

Taj Pharma stands as a benchmark in pharmaceutical excellence, both as a Dapagliflozin Tablet 10mg PAN India Manufacturer and a globally acclaimed supplier. With manufacturing units in Vapi, Gujarat, and corporate headquarters in Mumbai, the company offers cutting-edge production technologies and automated cleanroom facilities that comply with EU-GMP, WHO-GMP, and ISO 9001:2018 standards. Every Dapagliflozin Tablet 10mg batch undergoes stringent quality checks, real-time stability testing, and serialization for batch-level traceability. Taj Pharma not only ensures high therapeutic efficacy but also guarantees cost-effective pricing, making it the preferred choice for government tenders and private markets worldwide. With decades of expertise, the company is a top-tier Dapagliflozin Tablet 10mg Manufacturer, Supplier and PCD Pharma Franchise partner across PAN India and emerging markets in Africa, LATAM, and Southeast Asia.

🌍 Dapagliflozin Tablets 10mg: Target Export Markets and Logistics Excellence

The export strength of Taj Pharma lies in its ability to cater to diversified pharmaceutical demands with country-specific documentation and delivery protocols. As one of the most trusted Dapagliflozin Tablet 10mg Manufacturers India & Pioneer Exporters, the company serves partners in regulated and semi-regulated markets with FDA-registered facilities and PIC/S compliance. Countries like Vietnam, the Philippines, Nigeria, South Africa, and Ukraine rely on Taj Pharma for uninterrupted delivery of Dapagliflozin Tablet 10mg at the best price. The Mumbai-based logistics centre ensures swift sea and air freight execution, while the Vapi facility manages large-scale production to fulfill urgent and bulk requirements. Taj Pharma’s integrated supply chain guarantees on-time delivery and complete post-shipment support, reinforcing its leadership among Dapagliflozin Tablet 10mg Manufacturers PAN India, Suppliers, and Exporters.

📦 Technical Specification of Dapagliflozin Tablet 10mg

Dapagliflozin Tablet 10mg is available in a film-coated tablet form, designed for oral administration. Each tablet contains 10mg of Dapagliflozin as the active ingredient. The excipients used are of pharmaceutical grade, ensuring maximum bioavailability and patient tolerance. The tablets are packed in Alu-Alu or blister packs to maintain integrity against environmental moisture and oxidation. The recommended storage condition is at controlled room temperature, and the dosage should be taken exactly as prescribed by the healthcare provider.

📞 Call to Action for Global Buyers, Distributors, and PCD Pharma Franchise Seekers

Taj Pharma invites pharmaceutical importers, national distributors, and PCD Pharma Franchise entrepreneurs to collaborate for Dapagliflozin Tablet 10mg business across India and overseas markets. With unmatched product quality, transparent pricing, and robust compliance frameworks, Taj Pharma stands as the leading Dapagliflozin Tablet 10mg Manufacturer from Mumbai and a reliable partner for all pharma supply chain requirements. For inquiries related to the best price in Mumbai, Maharashtra Taj Pharma or partnerships in Gujarat, Delhi, or international regions, contact the company directly to initiate an enduring business collaboration.

♻ Conclusion: Sustainability and Legacy in Pharmaceutical Manufacturing

As a responsible Dapagliflozin Tablet 10mg Manufacturer & Supplier in India, Taj Pharma integrates environmental responsibility into its core business ethos. From recyclable packaging to energy-efficient manufacturing lines, every aspect is designed to contribute positively to the planet. This makes Taj Pharma not just a commercial success but also a sustainability leader among Dapagliflozin Tablet 10mg Manufacturers and exporters in India. Choose Taj Pharma for trust, excellence, and a partnership that goes beyond business.

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