Product Profile

Paracetamol Pediatric Oral Drops are a precision-dosed antipyretic and analgesic formulation designed specifically for infants and young children who require accurate weight-based dosing in minimal liquid volume. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech manufactures these drops with calibrated dropper precision and validated HPLC assay control, ensuring reliable fever management in every drop.

Manufacturing Advantage

Why Saar Biotech for Paracetamol Oral Drops?

Since {{ site.Params.founded }}, Saar Biotech has been a distinguished WHO-GMP certified leader in pharmaceutical manufacturing. We utilize advanced micronization and pH-stabilization protocols to deliver unmatched bioavailability for this Paracetamol Oral Drops formulation.

DCGI Approved

Comprehensive documentation and CDSCO support for rapid market entry in India.

Fast Turnaround

30-45 days lead time for new batches with state-of-the-art logistics.

Pan-India Supply & Contract Manufacturing

Batch Lead Time 30-45 Days (Domestic)
B2B Services Contract & Third-Party
Compliance DCGI & Schedule M Standards
Medical Intelligence

Clinical Q&A for Paracetamol Oral Drops

Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.

What are the clinical indications for Paracetamol Oral Drops?

Paracetamol Oral Drops are indicated for the symptomatic relief of fever and mild to moderate pain in infants and children, including teething pain, post-immunisation pyrexia, and fever associated with viral infections. The drops format enables precise weight-based dosing for the youngest patients who cannot swallow tablets or larger liquid volumes. It is a Schedule H prescription product.

What is the difference between the 100mg and 150mg strengths?

The 100mg per 1ml strength is typically used for younger infants and small children requiring lower per-dose Paracetamol quantities. The 150mg per 1ml strength is a more concentrated formulation suited for older infants and children where higher per-dose volumes are needed. Both strengths allow physicians to prescribe weight-appropriate doses with minimal liquid volume, reducing administration challenges.

What is the recommended dosing protocol for Paracetamol Drops?

Paracetamol should be dosed strictly by body weight, not age alone. The standard pediatric dose is 10 to 15 mg/kg per dose, administered every 4 to 6 hours as required, up to a maximum of 4 doses in 24 hours. The maximum daily dose must not exceed 60 mg/kg. At 100mg per 1ml, a child weighing 8kg would receive 0.8–1.2ml per dose. The calibrated dropper enables precise measurement.

What are the key safety precautions for Paracetamol Drops?

The primary safety concern is hepatotoxicity from overdose, caused by accumulation of the toxic NAPQI metabolite when glutathione pathways are overwhelmed. Parents must be counselled against concurrent use of other paracetamol-containing products. Strict weight-based dosing is mandatory. The drops should be administered using the calibrated dropper only — household spoons are not acceptable for this concentrated formulation.

Is this formulation suitable for neonates?

Paracetamol is widely used in neonates for fever and pain management, but dosing must be carefully calculated by weight and administered under physician supervision. Neonates have immature hepatic enzyme systems and may require extended dosing intervals. The 100mg per 1ml drops format allows precise neonatal dose titration. Use in neonates should always follow hospital or physician protocols.
Manufacturing Support

B2B Manufacturing Guide for Paracetamol Oral Drops

Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.

What pack sizes and packaging options are available for Paracetamol Drops contract manufacturing?
Saar Biotech manufactures Paracetamol Drops in the 15 ml format — the established commercial standard for pediatric oral drops in India. Packaging options include: 15ml PET amber or glass bottle with calibrated dropper and mono-carton, Drip-off Brand Name Embossed carton with sticker label and dropper, normal label with drip-off carton and dropper, printed cap plus dropper, and 360×15ml shipper configurations for high-volume distributor dispatch.
What is the MOQ for Paracetamol Drops third-party manufacturing?
The standard MOQ ranges from 5,000 to 10,000 units per SKU. Pediatric Paracetamol drops are a year-round essential product with consistent demand, and our automated 15ml filling lines in Baddi support both brand-entry volumes and large commercial runs.
What flavour options are available for pediatric Paracetamol drops?
Paracetamol API has a bitter note that requires expert taste-masking for infant acceptance. We offer Mixed Fruit, Strawberry, and sweet neutral flavour profiles that effectively mask bitterness while remaining appropriate for the very small dose volumes used in drops administration.
What analytical tests are performed on every manufacturing batch?
Every batch undergoes HPLC Assay confirming Paracetamol content (100mg or 150mg per 1ml) against IP specifications. pH and viscosity testing ensures the drops base remains stable and flows correctly through the calibrated dropper. Uniformity of dose testing confirms consistent active distribution throughout the 15ml fill volume. Microbial Limit Testing meets IP standards for oral liquid pediatric products. A Certificate of Analysis accompanies every B2B consignment.
Does Saar Biotech support brand name registration for Paracetamol Drops?
Yes. Our regulatory team supports DCGI brand name search and product registration for paediatric oral drop formulations. We provide Schedule H classification documentation, DCGI-compliant artwork, and ensure all labelling includes appropriate paediatric dosing schedules, overdose warnings, and fever management directions required for this product category.
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