Description

Sulfadoxine and Pyrimethamine Tablets (SP)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Sulfadoxine and Pyrimethamine Tablets in India. This fixed-dose combination (commonly known as SP) is a cornerstone antimalarial medication. It is the World Health Organization’s (WHO) recommended drug for Intermittent Preventive Treatment in pregnancy (IPTp) to prevent malaria in pregnant women, a critical intervention in malaria-endemic regions of Africa.

We offer Contract Manufacturing (Third Party) services for this high-impact public health product. SP is also used for the curative treatment of uncomplicated Plasmodium falciparum malaria (often in combination with Artesunate). Our WHO-GMP certified facility in Mumbai ensures strict adherence to quality standards, producing stable formulations that withstand tropical climates. Healthy Inc manages the export logistics, supplying National Malaria Control Programs, NGOs, and Ministries of Health across Africa and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Ensuring synergy and stability in a single tablet.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Synergistic Formulation: The efficacy of SP relies on the synergy between the two drugs. We use Geometric Mixing during granulation to ensure the small 25mg dose of Pyrimethamine is perfectly distributed amidst the bulkier 500mg of Sulfadoxine.

  • Dissolution: Both drugs must dissolve at compatible rates to block the malaria parasite’s folic acid pathway effectively. We optimize the binder and disintegrant ratio to ensure rapid release in the stomach.

  • Hardness: We compress tablets to a specific hardness that allows them to be transported on rough roads in rural supply chains without crumbling, yet still disintegrate quickly upon ingestion.

• The Exporter: Healthy Inc

  • IPTp Packaging: We offer specific 3-Tablet Blister Packs. This “Single Treatment Dose” format is ideal for mass distribution campaigns and antenatal care clinics, minimizing waste and ensuring the patient takes the full course.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test the release profile to ensure >60% of both drugs release within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for Sulfanilamide and other degradation products to ensure safety over the 3-year shelf life.

5. Why Use Sulfadoxine + Pyrimethamine?

It is the standard of care for preventing malaria in pregnancy.

• Mechanism: It is a “Sequential Blockade.” Sulfadoxine inhibits the enzyme dihydropteroate synthase, and Pyrimethamine inhibits dihydrofolate reductase. Together, they completely shut down the parasite’s ability to make folic acid (DNA), killing it.

• Key Indications:

  • IPTp (Pregnancy): Given to pregnant women at scheduled antenatal visits (after the 1st trimester) to prevent malaria, anemia, and low birth weight.

  • Curative Treatment: Used as a single-dose treatment for uncomplicated malaria (often where Artemisinin-based therapies are unavailable or as a partner drug).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Sulfadoxine Pyrimethamine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Can this be taken in the first trimester?

  A: Generally No. It is usually avoided in the first trimester due to potential teratogenicity, but is standard care for the 2nd and 3rd trimesters.

• Q: Is it a single dose?

  A: Yes. For curative treatment in adults, the standard dose is usually 3 tablets taken all at once. This convenience improves compliance significantly compared to multi-day regimens.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Curative Dose (Adults): 3 tablets (1500mg Sulfadoxine / 75mg Pyrimethamine) taken as a single dose.

• IPTp (Pregnancy): 3 tablets taken as a single dose at scheduled antenatal visits, starting in the 2nd trimester, at least one month apart.

• Administration: Swallow whole with plenty of water. Taking with food minimizes nausea.

9. Side Effects and Precautions

• Skin Reactions: Rare but serious risk of Stevens-Johnson Syndrome (SJS) due to the Sulfadoxine component. Discontinue immediately if a rash appears.

• Gastrointestinal: Nausea, vomiting, and stomatitis.

• Hematologic: Risk of bone marrow suppression (leukopenia) with prolonged use (which is why it is used as a single dose).

• Contraindications: Sulfa allergy, severe renal/hepatic failure, infants < 2 months.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light.