Pretomanid 200mg Tablets

Pretomanid 200mg Tablets Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

Pretomanid 200mg Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Pretomanid 200mg Tablets
   Each film-coated tablet contains:
   Eq. to Pretomanid ……………200mg
   Excipients…………………………q.s.
   Color:  Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Pretomanid is indicated, as part of a combination regimen with bedaquiline and linezolid, for the treatment of adults with pulmonary tuberculosis (TB) that is resistant to isoniazid, rifamycins, a fluoroquinolone and a second-line injectable antibacterial drug or adults

CAUTION & WARNING:

CAUTION:  Keep medicine out of reach of children.
Dispense in a tight, light-resistance, container.
Keep dry and foil intact

WARNING: concerning symptoms, such as vision changes, numbness, irregular heartbeat, or signs of liver problems.

STORAGE & DOSAGE:

STORAGE: Store in cool & Dry place. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing , Keep medicine out of reach of children. Read enclosed leaflet before use.

Dosage: As Directed By The Physician

Introduction  to  Pretomanid 200mg Tablets  

Pretomanid 200mg Tablets are an advanced treatment option for pulmonary tuberculosis (TB) that is resistant to conventional drugs. It is indicated as part of a combination regimen with bedaquiline and linezolid, specifically for adults with TB that is resistant to isoniazid, rifamycins, fluoroquinolones, and second-line injectable antibacterial drugs, or for those with treatment-intolerant/non-responsive multidrug-resistant TB (MDR-TB) or extensively drug-resistant TB (XDR-TB).

Pretomanid belongs to a class of drugs called nitroimidazoles, which are novel anti-bacterial agents developed to tackle resistant TB strains. Approved by the US FDA, Pretomanid in combination with bedaquiline and linezolid forms the BPaL regimen, a lifesaving solution for patients where conventional therapy fails.

Taj Pharma, a trusted Pretomanid 200mg Tablets manufacturer in India, is committed to providing high-quality, WHO-GMP certified formulations, making it a preferred choice for global buyers and distributors.

Global Demand for Pretomanid 200mg Tablets

Drug-resistant TB affects millions worldwide, particularly in countries with high TB prevalence such as India, South Africa, Russia, and parts of Southeast Asia. The rising incidence of MDR-TB and XDR-TB has increased the demand for Pretomanid 200mg Tablets, which are critical in curing resistant TB infections.

Global buyers, importers, and distributors increasingly rely on Indian pharmaceutical manufacturers like Taj Pharma due to their affordable pricing, quality assurance, and ability to meet international regulatory standards.

For Importers, Exporters & Buyers

Taj Pharma not only manufactures high-quality Pretomanid 200mg Tablets, but also provides a complete export solution for global partners, including documentation, regulatory support, and customized packaging.

Regulatory Documentation Provided

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP Certification

• EU-GMP Certification (on request for regulated markets)

• Drug Master File (DMF) / CTD Dossier

• Certificate of Analysis (COA)

• Stability Data and Method Validation Reports

Custom Packaging & Labeling

• Blister packs, strip packs, bottles, and bulk packaging options

• Multilingual packaging for global export markets

• Private labeling for distributors and PCD franchise partners

Shelf-Life, Storage & Dosage Form

• Shelf-life: 24–36 months depending on packaging

• Storage: Store in a cool, dry place below 25–30°C

• Dosage form: Film-coated tablets – 200mg strength

Export Certifications & Compliance

• WHO-GMP certified facilities

• ISO 9001:2015 compliant

• EU-GMP & USFDA guidelines adherence

• Compliance with International Pharmacopoeia standards (IP, BP, USP)

Target Countries & Export Markets

Taj Pharma exports Pretomanid 200mg Tablets to over 40 countries, including:

• United States, Canada, Brazil, Argentina

• United Kingdom, Germany, France, Italy, Spain

• Russia, Ukraine, Kazakhstan

• South Africa, Kenya, Nigeria, Egypt

• India, UAE, Saudi Arabia, Kuwait, Oman, Qatar

• Thailand, Vietnam, Malaysia, Philippines

Why is the Most Trusted Pretomanid 200mg Tablets Manufacturer & Exporter

1. State-of-the-Art Manufacturing Facilities

Taj Pharma’s Vapi, Gujarat facility is equipped with advanced manufacturing units for sterile and non-sterile pharmaceutical production. The facility follows WHO-GMP standards, ensuring quality, safety, and consistency in every batch of Pretomanid 200mg Tablets.

2. Affordable Pricing & Quality Assurance

Taj Pharma offers cost-effective Pretomanid tablets without compromising on efficacy and safety, making it a top choice for hospitals, distributors, and international buyers.

3. Global Presence & Supply Chain Support

With logistics and regulatory networks in over 40 countries, Taj Pharma assists partners with customs clearance, export documentation, and timely delivery, ensuring smooth business operations globally.

4. Leading Exporter to Top 20 Countries

Taj Pharma is a pioneer in exporting critical anti-TB drugs, including Pretomanid, to top markets such as:

• USA, UK, Germany, France, Italy

• South Africa, Kenya, Nigeria, Egypt

• UAE, Saudi Arabia, Kuwait, Oman, Qatar

• Thailand, Vietnam, Malaysia, Philippines

• Russia, Ukraine, Kazakhstan

Technical Product Specification  

If you are an importer, distributor, or PCD franchise partner looking for a reliable Pretomanid 200mg Tablets manufacturer in India, Taj Pharma is your trusted partner.

📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com

Partner today for competitive pricing, regulatory support, and seamless supply chain solutions for Pretomanid 200mg Tablets exports from India.

Top 20 FAQs  

Q1. What is Pretomanid 200mg Tablets used for?
A1. It treats MDR-TB and XDR-TB as part of a combination therapy with bedaquiline and linezolid.

Q2. Who is the best Pretomanid 200mg Tablets manufacturer in India?
A2. Taj Pharma Ltd, Vapi, Gujarat is a leading WHO-GMP certified manufacturer.

Q3. Can Pretomanid 200mg Tablets be exported worldwide?
A3. Yes, Taj Pharma exports to over 40 countries globally.

Q4. Is Pretomanid available for PCD Pharma Franchise?
A4. Yes, Taj Pharma provides PCD Pharma Franchise opportunities across India.

Q5. What certifications does Taj Pharma hold?
A5. WHO-GMP, ISO 9001:2015, COPP, DMF/CTD Dossier, EU-GMP compliance.

Q6. Can buyers request custom packaging?
A6. Yes, private labeling and custom packaging are available.

Q7. Are there any side effects of Pretomanid 200mg Tablets?
A7. Possible side effects include decreased platelets, hemoglobin, white blood cells, headache, nausea, diarrhea, elevated liver enzymes, and neuropathy.

Q8. Can Pretomanid 200mg Tablets be taken alone?
A8. No, it should be taken only as part of the BPaL combination regimen.

Q9. How should Pretomanid 200mg Tablets be stored?
A9. Store in a cool, dry place below 25–30°C.

Q10. What is the shelf-life?
A10. 24–36 months depending on packaging and storage.

Q11. Is Pretomanid FDA approved?
A11. Yes, approved for XDR-TB and treatment-intolerant/non-responsive MDR-TB.

Q12. Can it be used in pregnancy?
A12. Consult a physician; safety in pregnancy is not established.

Q13. Are bulk orders available?
A13. Yes, bulk supply is available for distributors, hospitals, and global buyers.

Q14. What dosage form is available?
A14. Film-coated tablets – 200mg strength.

Q15. Is Taj Pharma affordable compared to branded alternatives?
A15. Yes, they provide cost-effective Pretomanid tablets for global markets.

Q16. Which countries import Pretomanid from Taj Pharma?
A16. USA, UK, Germany, South Africa, Nigeria, UAE, Saudi Arabia, Vietnam, Philippines, and others.

Q17. Can Taj Pharma provide DMF/CTD dossiers?
A17. Yes, full regulatory documentation is available.

Q18. Does Taj Pharma manufacture other anti-TB drugs?
A18. Yes, Taj Pharma produces multiple novel anti-TB and anti-infective formulations.

Q19. Is Pretomanid 200mg Tablets available in Mumbai at best price?
A19. Yes, Taj Pharma offers competitive pricing PAN India and in Mumbai.

Q20. Why choose Taj Pharma for Pretomanid 200mg Tablets exports?
A20. Because of WHO-GMP certified quality, global logistics support, affordable pricing, and regulatory expertise.