Obeticholic Acid Tablets 10mg

Obeticholic Acid Tablet 10mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Obeticholic Acid Tablet 10mg
• Obeticholic Acid Tablet 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Obeticholic Acid Tablet 10mg
  Each Film-coated tablet contain:
  Obeticholic Acid …………………………10mg
  Excipients………………………………………..q.s.
  Colour: Titanium Dioxide IP
• Obeticholic Acid Tablet 5mg
  Each Film-coated tablet contain:
  Obeticholic Acid …………………………5mg
  Excipients………………………………………..q.s.
  Colour: Quinoline Yellow Lake

THERAPEUTIC INDICATIONS:

•  Obeticholic acid can cause liver damage, sometimes serious enough to require liver transplantation or cause death, especially in patients that have cirrhosis (scarring) of the liver. Tell your doctor if you have or have ever had cirrhosis of the liver. Your doctor may tell you not to take obeticholic acid. If you experience any of the following symptoms while taking obeticholic acid, call your doctor immediately: yellowing of the skin or eyes, dark urine, black tarry stools, coughing up or vomiting blood, swelling in and around the stomach area, confusion, slurred speech, anxiety, mood swings, or changes in personality.

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 at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture.
• Dosage: As directed by the Physician

1. Introduction to Obeticholic Acid Tablets 10mg

Obeticholic Acid Tablets 10mg are a highly specialized pharmaceutical formulation used globally for the treatment of various cholestatic liver diseases. The medicine plays a powerful role in managing:

• Primary Biliary Cholangitis (PBC)

• Cholestatic liver damage

• Alcoholic fatty liver disease

• Non-alcoholic fatty liver disease (NAFLD)

• NASH (Non-Alcoholic Steatohepatitis)

The drug works by inhibiting bile acid synthesis, increasing bile secretion, reducing liver toxicity, and thereby improving liver function and metabolism.

With an increasing global burden of fatty liver diseases, the international demand for Obeticholic Acid Tablets 10mg has grown exponentially—especially in regulated and semi-regulated markets.

Among the top global manufacturers, Taj Pharma stands out as the most reputable and trusted name.

2.  The Most Reliable Obeticholic Acid Tablets 10mg Manufacturer in India

Taj Pharma, Vapi (Gujarat), India, is a well-known and widely recognized Obeticholic Acid Tablets 10mg Manufacturer, Supplier, and Exporter. The company guarantees:

• High purity

• Zero contamination

• Fully compliant WHO-GMP production

• Best-in-class quality control

• Stringent pharma regulatory compliance

Taj Pharma’s formulation is known for its excellent stability, therapeutic accuracy, and global acceptance across 75+ countries.

Mechanism of Action – How Obeticholic Acid Works

Obeticholic Acid regulates:

• Bile acid synthesis

• Lipid metabolism

• Glucose levels

By increasing bile acid excretion, it prevents accumulation inside the liver—protecting hepatocytes from toxic damage. This results in better liver performance, reduced inflammation, and slower disease progression.

Patients taking this medicine may experience mild side effects such as:

• Itching

• Fatigue

• Abdominal discomfort

• Joint pain

• Constipation

• Dizziness

• Rash

• Peripheral edema

However, under medical supervision, it remains one of the safest and most effective treatments for PBC and related liver disorders.

3. In-depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

Taj Pharma supplies a complete regulatory documentation package, including:

• WHO-GMP Certificate

• EU-GMP / PICs compliance (where applicable)

• COA (Certificate of Analysis)

• MOA (Method of Analysis)

• MSDS (Material Safety Data Sheet)

• Stability data (Real-time & Accelerated)

• CTD / ACTD Dossier (Modules 1–5)

• COPP (Certificate of Pharmaceutical Product)

• Free Sale Certificate

• Batch Manufacturing Records (BMR)

• FDA-compliant documentation for export

These documents significantly simplify registration in international markets.

Custom Packaging & Private Labeling

Taj Pharma provides tailor-made packaging solutions:

• Alu-Alu / Blister pack options

• HDPE bottle packaging

• Branding support for private-label buyers

• Customized artwork with buyer country regulatory compliance

• Bilingual packaging (English + target language)

Dosage Form, Shelf-life & Storage

• Dosage Strength: Obeticholic Acid Tablets 10mg

• Shelf-life: 24 to 36 months depending on buyer’s requirement

• Storage: Store below 25°C in a cool, dry environment, away from sunlight

• Container: Alu-Alu strips or HDPE bottles

Key Export Markets for Taj Pharma

Taj Pharma exports Obeticholic Acid Tablets 10mg to:

• Latin America

• Africa

• CIS Nations

• Middle East

• South-East Asia

• Caribbean

• Eastern Europe

Major countries include:

Vietnam, Myanmar, Philippines, Kenya, Nigeria, Uganda, UAE, Iraq, Yemen, Kazakhstan, Nepal, Sri Lanka, Ghana, Tanzania, Peru, Colombia, Bolivia, Chile, Dominican Republic.

4. Why Taj Pharma is the Best Obeticholic Acid Tablets 10mg Manufacturer & Exporter in India

A. State-of-the-Art Manufacturing Facilities

Taj Pharma operates world-class facilities in Vapi, Gujarat, built as per:

• WHO-GMP

• EU-GMP

• US-FDA guidelines

• PIC/S norms

With automated production, HEPA filtration, and strict contamination control, quality is unmatched.

B. Affordable Pricing & Global Supply Capability

Taj Pharma ensures the best price in India, especially for large-volume buyers, government tenders, and pharmaceutical distributors.

They offer:

• PAN India supply

• Export to 75+ countries

• Fast delivery

• Pharma contract manufacturing

• PCD Pharma Franchise support

C. Dedication to Quality Assurance

Each batch undergoes:

• HPLC testing

• Dissolution profiling

• Impurity analysis

• Microbial testing

• Uniformity checks

• Stability validation

This ensures consistent global acceptance.

D. Top 20 Countries  

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

5. Technical Product Specification Table

6. PAN India & Global Branding Titles  

• Obeticholic Acid Tablets 10mg PAN India Manufacturer

• Obeticholic Acid Tablets 10mg Manufacturer Supplier and PCD Pharma Franchise

• Obeticholic Acid Tablets 10mg Manufacturers PAN India Suppliers Exporters

• Obeticholic Acid Tablets 10mg Manufacturer from Mumbai / Vapi / Gujarat

• Obeticholic Acid Tablets 10mg Best Price in Mumbai Maharashtra Taj Pharma

• Leading #1 Obeticholic Acid Tablets 10mg Manufacturer & Supplier in India

• Obeticholic Acid Tablets 10mg Pioneer Exporters India

7. Call to Action  

If you are a pharmaceutical distributor, importer, bulk buyer, tender participant, or PCD Pharma entrepreneur, now is the ideal time to partner with Taj Pharma.

Taj Pharma offers:

✓ Best pricing
✓ High-quality WHO-GMP products
✓ Fast export documentation
✓ Private labeling
✓ PAN India supply
✓ Global logistics support

For business inquiries:
📩 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com

8. Top 20 FAQs 

1. What are Obeticholic Acid Tablets 10mg used for?

They treat Primary Biliary Cholangitis and improve liver function.

2. Is Taj Pharma the leading manufacturer in India?

Yes—Taj Pharma is the #1 WHO-GMP certified manufacturer for Obeticholic Acid Tablets 10mg.

3. Do you provide export documentation?

Yes—COPP, CTD Dossier, COA, WHO-GMP, FSC, and more.

4. Can buyers request private labeling?

Absolutely. Custom branding & packaging are available.

5. What is the shelf-life of the tablets?

24–36 months with proper storage.

6. Which countries does Taj Pharma export to?

75+ global markets including Africa, Asia, CIS & Latin America.

7. Is Obeticholic Acid effective for NAFLD?

It helps improve liver metabolism in NAFLD patients.

8. What certifications do you hold?

WHO-GMP, ISO, COPP, and compliance for regulated markets.

9. Do you offer PCD Pharma Franchise?

Yes—PAN India PCD opportunities available.

10. What side effects may occur?

Mild itching, fatigue, discomfort, or rash.

11. Can it be supplied in bulk?

Yes—large export quantities available.

12. Do you support registration in foreign countries?

Yes—full technical dossier support.

13. What packaging options are available?

Alu-Alu, blister packs, HDPE bottles.

14. How is the medicine stored?

Below 25°C in a dry, cool place.

15. Does Taj Pharma supply government tenders?

Yes—national and international tenders.

16. Can I get best pricing for bulk orders?

Yes—discounted rates for volume buyers.

17. Is the product tested for impurities?

Every batch undergoes stringent QC tests.

18. What is the MOQ for export?

Flexible—depends on geography and regulations.

19. Do you offer door-to-port shipping?

Yes—global logistics support is provided.

20. Why choose Taj Pharma?

Quality, affordability, documentation support & global trust.

Taj Pharma remains the leading Obeticholic Acid Tablets 10mg Manufacturer, Supplier & Exporter in India, delivering unmatched quality, WHO-GMP certified production, and global market expertise. With strong technical capabilities, dedicated R&D, and world-class manufacturing infrastructure, Taj Pharma is the preferred pharmaceutical partner for importers, distributors, and PCD franchise buyers worldwide.