Obeticholic Acid Tablet 5mg

Obeticholic Acid Tablet 5mg 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 USP
• Obeticholic Acid Tablet 5mg
  Each Film-coated tablet contain:
  Obeticholic Acid …………………………5mg
  Excipients………………………………………..q.s.
  Colour: Ferric Oxide of Red USP-NF

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: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

• Storage: Store at 20° to 25°C (68° to 77°F).
• Dosage: As directed by the Physician

Attach dispensing label here.

Introduction to Obeticholic Acid Tablet 5mg

Obeticholic Acid Tablet 5mg is an FXR agonist that works by stimulating the Farnesoid X receptor (FXR)—responsible for regulating bile acid synthesis, lipid metabolism, and glucose levels. By reducing the bile acid load in the liver, this medicine prevents hepatocellular damage and supports overall liver function.

Key Medical Benefits

• Protects liver cells from bile-acid-induced toxicity

• Reduces hepatic inflammation

• Improves bile secretion

• Enhances metabolic balance

• Recommended in chronic cholestatic liver diseases

Growing Global Demand

The increasing global incidence of NAFLD, NASH, and PBC has resulted in a strong demand for Obeticholic Acid Tablet 5mg manufacturers and exporters. Taj Pharma is among the top suppliers meeting international demand with compliant, export-ready formulations.

Why Importers, Distributors & PCD Buyers Prefer Us

Taj Pharma is among the few Indian manufacturers offering full regulatory documentation, WHO-GMP compliance, competitive pricing, and global supply chain expertise for Obeticholic Acid Tablet 5mg.

Regulatory Documentation Provided

Taj Pharma offers a complete set of export-ready documents:

• COA (Certificate of Analysis)

• MOA & Stability Data

• Batch Manufacturing Records

• COPP (Certificate of Pharmaceutical Product)

• CTD/eCTD Dossiers

• WHO-GMP & EU-GMP Compliance

• Free Sale Certificate

• MSDS

• Third-Party Test Reports

This makes the procurement process smooth for international buyers, government agencies, and private label marketers.

Custom Packaging & Labelling Options

Taj Pharma provides customizable export packaging:

• Alu-Alu / Blister packs

• Bottle packaging

• Monocarton, bulk, or private-label customization

• Multilingual packaging (English, French, Arabic, Russian, Spanish, etc.)

• Temperature-controlled shipping

Each batch is barcoded and traceable for maximum transparency.

Shelf-Life, Storage & Dosage Form

• Dosage Form: Oral tablet

• Strength: 5mg

• Shelf Life: Typically 24–36 months

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

• Administration: Preferably after meals; one dose should be taken after the evening meal

Export Certifications

Taj Pharma’s manufacturing is supported by globally recognized certifications:

• WHO-GMP

• ISO 9001:2015

• ISO 14001

• EU-GMP (where applicable)

• COPP

• USFDA-style documentation

• State FDCA approvals

This regulatory strength enhances acceptance in international tenders and markets.

Target Export Countries

Taj Pharma exports Obeticholic Acid Tablet 5mg to:

• Vietnam

• Philippines

• Myanmar

• Cambodia

• UAE

• Oman

• Iraq

• Yemen

• Kenya

• Tanzania

• Uganda

• Ethiopia

• Nigeria

• South Africa

• Sri Lanka

• Bangladesh

• Nepal

• Afghanistan

• Russia

• Ukraine

  Why Taj Pharma Is the Most Trusted Manufacturer & Global Exporter

 State-of-the-Art Manufacturing – Vapi, Gujarat

Taj Pharma’s ultra-modern, automated, HVAC-controlled manufacturing plant ensures:

• Sterile and hygienic production

• Zero contamination

• Precision API integration

• High purification cycle

• Strict quality audits

The facility meets WHO-GMP, PIC/S, and EU-GMP norms.

  Affordable Pricing & Global Quality Assurance

Taj Pharma ensures:

• Competitive global pricing

• Stringent QC checks for each batch

• Stability testing under ICH guidelines

• Cost-effective bulk export rates

  Global Supply Chain & Shipping Support

Taj Pharma supports its overseas buyers with:

• Fast documentation

• Temperature-controlled freight

• Door-to-port logistics

• Seamless customs clearance

The company’s strong supply chain access ensures reliable shipment to over 90+ countries.

 Top 20 Countries  

India | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile

 Technical Product Specification 

 Call to Action  

If you are a pharmaceutical importer, distributor, tender participant, or PCD pharma franchise holder, Taj Pharma invites you to collaborate for long-term business growth.

Contact Taj Pharma for:

• Bulk manufacturing orders

• Third-party manufacturing

• PCD franchise partnerships

• Tender supply contracts

• Global export quotations

Email: info@tajpharma.com
Website: www.tajpharma.com
Head Office: Mumbai, Maharashtra
Manufacturing Unit: Vapi, Gujarat, India

 Top 20 FAQs  

1. What is Obeticholic Acid Tablet 5mg used for?

It treats cholestatic liver diseases, PBC, NAFLD, and improves bile flow.

2. Who is the best Obeticholic Acid Tablet 5mg Manufacturer in India?

Taj Pharma is widely regarded as the leading manufacturer due to WHO-GMP standards and global export quality.

3. Does Taj Pharma export worldwide?

Yes, Taj Pharma exports to 90+ countries across Asia, Middle East, Africa, CIS, and LATAM.

4. What certifications does Taj Pharma hold?

WHO-GMP, ISO, COPP, state FDA approvals, and CTD documentation.

5. Do you offer private labeling?

Yes, full-scale private-label customization is available.

6. What is the dosage of Obeticholic Acid Tablet 5mg?

It is usually taken after meals; one dose after the evening meal is recommended.

7. What are the common side effects?

Itching, fatigue, abdominal discomfort, rash, joint pain, dizziness, and edema.

8. What is the shelf life?

24–36 months depending on packaging.

9. Do you provide samples?

Yes, samples can be provided for regulatory and quality evaluation.

10. Is bulk export pricing available?

Yes, Taj Pharma offers competitive bulk rates.

11. Is it safe for all patients?

Only under medical supervision, especially for those with severe liver conditions.

12. What packaging options are available?

Blister, Alu-Alu, bottle packs, and custom packs.

13. Can Taj Pharma support tender documentation?

Yes, full tender documentation is provided.

14. Do you offer CTD dossiers?

Yes, CTD/eCTD formats are available.

15. Is door-to-port shipping supported?

Yes, global logistics support is available.

16. Do you supply to government agencies?

Yes, Taj Pharma is an approved supplier.

17. What is the MOQ?

Flexible MOQ depending on buyer requirements.

18. Can I order for PCD franchise?

Yes, PCD franchise opportunities are open PAN India.

19. Do you supply from Mumbai?

Yes, with manufacturing in Vapi and corporate office in Mumbai.

20. Why choose Taj Pharma over other suppliers?

Superior quality, best pricing, full regulatory support, and unmatched global export experience.