GENERIC NAME OF THE MEDICINAL PRODUCT:
Pitavastatin Calcium Tablet 2mg
Pitavastatin Calcium Tablet 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film coated Contains:
Pitavastatin Calcium USP
Equivalent to Pitavastatin………… 1mg
Excipients……………………………q.s.
Colours: Titanium Dioxide
b) Pitavastatin Calcium Tablet 2mg
Each Film coated Contains:
Pitavastatin Calcium USP
Equivalent to Pitavastatin………… 2mg
Excipients……………………………q.s.
Colours: Iron Oxide
c) Pitavastatin Calcium Tablet 4mg
Each Film coated Contains:
Pitavastatin Calcium USP
Equivalent to Pitavastatin………… 4mg
Excipients……………………………q.s.
Colours: Ferric oxide yellow
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
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:
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
Pitavastatin Calcium Tablet 2mg Technical Specification:
| Product Name: |
Pitavastatin Calcium Tablet |
| Brand Name: | Generics |
| Strength: | 1mg, 2mg, 4mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via oral Route |
| Packing: | 100s, 500s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-hyperlipidaemic, Cardiology |
| Indication: | Pitavastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Pitavastatin Calcium Tablet 1mg
- Pitavastatin Calcium Tablet 2mg
- Pitavastatin Calcium Tablet 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Pitavastatin Calcium Tablet 1mg
Each Film coated Contains:
Pitavastatin Calcium USP
Equivalent to Pitavastatin………… 1mg
Excipients……………………………q.s.
Colours: Titanium Dioxide - b) Pitavastatin Calcium Tablet 2mg
Each Film coated Contains:
Pitavastatin Calcium USP
Equivalent to Pitavastatin………… 2mg
Excipients……………………………q.s.
Colours: Iron Oxide - c) Pitavastatin Calcium Tablet 4mg
Each Film coated Contains:
Pitavastatin Calcium USP
Equivalent to Pitavastatin………… 4mg
Excipients……………………………q.s.
Colours: Ferric oxide yellow
THERAPEUTIC INDICATIONS:
- Pitavastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body
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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
- Dosage: As directed by the Physician.
Introduction to Pitavastatin Calcium Tablet 2mg
Pitavastatin Calcium Tablet 2mg is a prescription statin medication used to lower LDL (“bad” cholesterol), raise HDL (“good” cholesterol), and reduce triglycerides in patients with primary hyperlipidemia or mixed dyslipidemia. This drug is essential for cardiovascular risk management globally and is a preferred option due to its potent efficacy and minimal drug interaction profile.
Given the rising incidence of cardiovascular disease and lifestyle-related disorders, the demand for Pitavastatin Calcium Tablet 2mg is steadily increasing across developed and developing markets.
In-Depth Product Information for Importers, Exporters & Buyers
Regulatory Documentation Provided
Taj Pharma ensures full regulatory compliance and provides:
- WHO-GMP Certificates
- EU-GMP (for EU Markets)
- Certificate of Pharmaceutical Product (COPP)
- CTD/ACTD Dossiers
- Manufacturing License
- Stability Data
- Bioequivalence Studies (if required)
Custom Packaging & Private Labeling
Taj Pharma offers tailor-made solutions:
- Custom pack design & multilingual labeling
- Blister or bottle packaging options
- Temperature-controlled shipment
- OEM & third-party labeling
Shelf-Life, Storage & Dosage Form
- Shelf-Life: 24 to 36 months
- Storage: Store below 30°C, protect from moisture
- Dosage Form: Film-coated tablets, 2mg strength
- Route of Administration: Oral
Export Certifications
Taj Pharma is a globally certified pharmaceutical exporter with:
- WHO-GMP approval
- EU-GMP (Europe)
- US FDA-compliant facility
- ISO 9001:2015 & ISO 14001:2015
Target Countries & Export Markets
Taj Pharma exports Pitavastatin Calcium Tablet 2mg to over 40 countries, including:
- USA, UK, Germany, France, UAE
- Kenya, Nigeria, South Africa, Tanzania
- Vietnam, Philippines, Thailand, Indonesia
- Brazil, Peru, Mexico, Chile
- Russia, Kazakhstan, Ukraine
Why is the Most Trusted Manufacturer/Supplier/Exporter
State-of-the-Art WHO-GMP Manufacturing Facility
Taj Pharma manufactures Pitavastatin Calcium Tablet 2mg at its world-class facility in Vapi, Gujarat, India. The site is certified by WHO-GMP and complies with stringent regulatory standards, including EU-GMP.
Affordable Pricing with Unmatched Quality
Taj Pharma offers competitive rates to help global partners maintain affordability in their respective markets while ensuring the highest product quality standards.
Global Presence & Logistics Support
Taj Pharma has strong supply chain capabilities, facilitating:
- PAN India PCD Pharma franchise
- Direct B2B exports
- Swift regulatory support
- End-to-end shipping and documentation
Top 20 Countries Exporting
Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic
Technical Specification Table
| Parameter | Details |
|---|---|
| Product Name | Pitavastatin Calcium Tablet 2mg |
| Strength | 2mg |
| Form | Film-coated Tablets |
| Packaging | Blister Pack / Bottle Pack |
| Storage Conditions | Below 30°C, dry and moisture-free |
| Shelf-Life | 24-36 months |
| Certifications | WHO-GMP, EU-GMP, COPP, ISO |
| Origin | Vapi, Gujarat, India |
| Brand Name (if applicable) | Customizable / Generic available |
| HSN Code | 30049099 |
Are you looking for a reliable Pitavastatin Calcium Tablet 2mg manufacturer in India? Taj Pharma is your trusted partner for quality-driven pharmaceutical manufacturing and global supply. Whether you’re a distributor, importer, or hospital procurement agency, Taj Pharma offers:
- Custom pricing for bulk orders
- Worldwide logistics & support
- Regulatory document assistance
Contact Us Today: Visit www.tajpharma.com or email export@tajpharma.com for quotations, samples, or more information.
Top 20 FAQs
Q1. What is Pitavastatin Calcium Tablet 2mg used for?
A: It’s used to treat high cholesterol and lower cardiovascular risks.
Q2. Is Taj Pharma a certified manufacturer?
A: Yes, WHO-GMP & EU-GMP certified.
Q3. Can I get customized packaging?
A: Absolutely. OEM & private label options available.
Q4. Does Taj Pharma export to Africa?
A: Yes, including Kenya, Nigeria, and South Africa.
Q5. Is the product available for PCD Pharma franchise?
A: Yes, PAN India PCD options are open.
Q6. What’s the shelf life of Pitavastatin 2mg tablets?
A: Typically 24-36 months under proper storage.
Q7. Are bioequivalence studies available?
A: Provided upon client request.
Q8. Which forms of packaging are offered?
A: Blister, strip, or bottle packs.
Q9. What is the manufacturing location?
A: Vapi, Gujarat, India.
Q10. Is this medicine available for tender supply?
A: Yes, including government tenders.
Q11. Does Taj Pharma provide samples?
A: Yes, for serious buyers and registration.
Q12. Is the product available in CTD format?
A: Yes, complete CTD/ACTD dossier is available.
Q13. Are stability data reports provided?
A: Yes, real-time and accelerated.
Q14. What are the side effects of Pitavastatin?
A: Mild ones include diarrhea and muscle pain; serious ones are rare.
Q15. Is temperature-controlled shipping possible?
A: Yes, as per product requirements.
Q16. Can Taj Pharma support in product registration?
A: Yes, including dossier submission.
Q17. Is there an MOQ (Minimum Order Quantity)?
A: Flexible depending on region and order size.
Q18. What are Taj Pharma’s top export destinations?
A: USA, UK, EU, Asia, Africa & LATAM.
Q19. Can you help with tenders and institutional supply?
A: Yes, Taj Pharma is an experienced tender supplier.
Q20. What is the lead time for export?
A: 2-4 weeks depending on destination and quantity.






