Description

Nystatin Vaginal Tablets (100,000 IU)

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 Nystatin Vaginal Tablets in India. These tablets (also known as Pessaries) are a targeted Antifungal therapy used for the treatment of vulvovaginal candidiasis (thrush). Nystatin is a classic polyene antifungal that is highly effective against Candida albicans and is considered a safe first-line treatment, even often during pregnancy.

We offer Contract Manufacturing (Third Party) services for this gynecological product. Nystatin is sensitive to heat and moisture. Our WHO-GMP certified facility in Mumbai utilizes controlled-humidity suites to manufacture these tablets. We also provide Vaginal Applicators within the packaging to ensuring hygienic and deep insertion for maximum efficacy. Healthy Inc manages the export logistics, supplying pharmacies and women’s health clinics across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Local delivery requires specific formulation traits.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Rapid Disintegration: Unlike oral tablets, vaginal tablets must dissolve in a low-moisture environment (vaginal fluid). We use specialized Super-Disintegrants and foaming agents (in some formulations) to ensure the tablet breaks down quickly upon insertion to coat the vaginal walls with the antifungal agent.

  • Shape & Comfort: We use dedicated tooling to create Diamond or Oval shaped tablets with smooth edges. This ergonomic design makes insertion easier and comfortable for the patient.

  • Applicator Integration: We have established supply chains for medical-grade plastic applicators, which are blister-packed alongside the tablets or included in the carton.

• The Exporter: Healthy Inc

  • Moisture Protection: Nystatin loses potency if exposed to humidity. We use Alu-Poly Foil Strips that provide a hermetic seal until the moment of use.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Microbiological Assay: We measure potency in International Units (IU) rather than just weight, ensuring the biological activity against yeast is standardized.

• Disintegration: Tested in simulated vaginal fluid to ensure release within 30 minutes.

• Purity: Strict limits on related substances and heavy metals.

5. Why Use Nystatin Vaginal Tablets?

It is a safe, non-systemic option for thrush.

• Mechanism: Nystatin binds to ergosterol, a vital component of the fungal cell membrane. This creates pores in the membrane, causing the fungus to leak electrolytes and die.

• Key Indications:

  • Vaginal Candidiasis: Treatment of yeast infections (Thrush).

  • Prophylaxis: Prevention of fungal overgrowth in patients taking broad-spectrum antibiotics.

• Advantage: Unlike oral antifungals (Fluconazole), Nystatin is not absorbed into the bloodstream. It acts locally, making it safer for patients who cannot tolerate systemic drugs (e.g., liver issues or pregnancy).

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 Nystatin Vaginal Tablets?

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

• Q: Can I use this during my period?

  A: Yes. Continue the treatment even if menstruation starts. However, do not use tampons, as they may absorb the medication. Use pads instead.

• Q: Is it safe for pregnancy?

  A: Yes. Because it is not absorbed into the blood, Nystatin is generally considered safe for use during pregnancy (Category A/B), but always consult a doctor first.

• Q: Is it an oral tablet?

  A: NO. These are for Vaginal Use Only. Do not swallow.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet (100,000 IU) inserted high into the vagina nightly for 14 days.

• Higher Dose: Sometimes two tablets are prescribed nightly for severe infections.

• Administration: Wash hands. Place tablet in the applicator. Lie on back with knees bent. Insert applicator deep into the vagina and push the plunger to release the tablet. Wash applicator with warm soapy water after use.

9. Side Effects and Precautions

• Local Irritation: Mild burning or stinging upon insertion (rare).

• Latex Interaction: The tablet ingredients may weaken latex condoms or diaphragms. Rely on alternative contraception during treatment.

• Hypersensitivity: Discontinue if severe rash or swelling occurs.

10. Storage Instructions

• Store below 25°C in a cool, dry place.

• Refrigeration is often recommended in very hot climates to prevent the tablet from softening too much before use.