Paracetamol Oral Drops
Paracetamol IP Pediatric Oral Drops · Analgesics & Pain Relief, Anti-Pyretic, Pediatric Care
Paracetamol 100mg Drops
Paracetamol 150mg Drops
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.
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
Description & Therapeutic Class
Paracetamol Oral Drops belong to the Oral Drops category within the Analgesics & Pain Relief, Anti-Pyretic, and Pediatric Care therapeutic segments. The drops format is clinically preferred for infants and young children because it allows precise weight-based dosing in minimal liquid volumes.
The two strengths — 100mg per 1ml and 150mg per 1ml — provide physicians with flexibility in prescribing based on the child’s age, weight, and clinical presentation. The concentrated format means a full therapeutic dose is delivered in 0.5–1.5ml, reducing the volume burden for infants who may resist larger liquid doses.
For pharmaceutical marketing companies, pediatric Paracetamol drops are a foundational essential medicine with consistent year-round demand. Saar Biotech manufactures it from our manufacturing facility in Baddi with validated API quality control.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture Paracetamol Drops using a precision-controlled liquid formulation process that ensures accurate dosing, infant-appropriate taste, and packaging reliability.
Calibrated Dropper Precision: The dropper tip and bulb assembly deliver consistent, repeatable volume per squeeze — calibrated specifically for the viscosity of this drops base. This ensures accurate 0.5ml and 1ml doses for weight-based infant prescribing.
Concentrated Active Uniformity: At 100mg or 150mg per 1ml, any non-uniformity creates large dose errors. Our quality protocols include uniformity-of-dose checks across the fill volume, confirming consistent active delivery from the first drop to the last.
Infant-Appropriate Taste Masking: Paracetamol’s bitter profile is effectively masked using mixed fruit and sweet neutral flavour systems that remain acceptable at the small dose volumes used in drops administration.
Premium 15ml Dropper Pack Execution: Drip-off brand embossed cartons, amber PET or glass bottles, and quality printed caps give pediatric brands a professionally credible appearance.
Pan-India Supply & Contract Manufacturing
Key Indications & Clinical Use
Paracetamol Oral Drops are manufactured and supplied by Saar Biotech for the following established clinical indications:
- Fever in Infants & Children: First-line antipyretic for fever associated with viral infections, colds, and post-immunisation reactions
- Teething Pain: Relief from pain and discomfort associated with teething
- Post-Immunisation Pyrexia: Management of fever following vaccination
- Mild to Moderate Pain: Headache, toothache, sore throat, and musculoskeletal pain in children
Schedule H — Requires valid medical prescription. Strict weight-based dosing required.
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Manufacturing Integrity
Paracetamol acts primarily as a centrally-mediated analgesic and antipyretic. It inhibits central cyclooxygenase pathways — specifically the synthesis of prostaglandins in the hypothalamic thermoregulatory centre. This hypothalamic action facilitates vasodilation and sweating to reduce fever. The drops format delivers rapid absorption, with Tmax typically achieved within 30 to 60 minutes.
Manufacturing Integrity
- Solution Stability: The drops base maintains Paracetamol’s chemical stability for 24 months under tropical storage conditions.
- Dropper Calibration: Per-squeeze volume verified against the finished product’s viscosity.
- Taste Masking: Flavour systems engineered specifically for the concentrated drops format.
Pan-India Supply & Contract Manufacturing
Pharmacokinetics & B2B Commercial Value
- Rapid Fever Reduction: Tmax 30–60 minutes — fast, visible clinical outcome.
- Drops Segment Premium Pricing: Pediatric oral drops command a price premium over suspension formats.
- Year-Round Demand: Essential medicine with consistent prescription volume.
- 360×15ml Shipper Economics: Optimised logistics for high-volume distributor dispatch.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for Paracetamol Oral Drops from our dedicated oral liquid manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Oral drops filling line with amber PET and glass bottle filling, calibrated dropper assembly, and carton packing.
- Capacity: From 5,000-unit brand-entry batches to 2,00,000+ unit commercial runs.
- Quality Lab: In-house GLP-certified lab with HPLC assay, uniformity-of-dose testing, pH, viscosity, MLT, and dropper calibration verification.
- Turnaround: New orders — 30 to 45 working days. Repeat orders — 20 to 25 working days.
- Packaging: 15ml amber PET or glass bottle with calibrated dropper; drip-off brand embossed carton, sticker label, printed cap.
- MOQ: 5,000–10,000 units per SKU.
Pan-India Supply & Contract Manufacturing
Storage & Handling Guidelines
- Temperature and Light Protection: Store below 30°C in the original amber bottle away from direct sunlight.
- Tight Closure Between Doses: Dropper bottle must be capped tightly after every use.
- No Freezing: Sub-zero temperatures alter the drops base viscosity profile.
- Dropper Hygiene: The dropper tip must not contact the infant’s mouth during administration.
Pan-India Supply & Contract Manufacturing
Quality Control & Compliance
Every commercial batch is quarantined until it passes a comprehensive release protocol:
- HPLC Assay: Confirmation of Paracetamol content per label claim.
- Uniformity of Dose: Homogeneous active distribution confirmed.
- pH and Viscosity Testing: Stability and dropper calibration verified.
- Microbial Limit Testing (MLT): IP-compliant testing for oral pediatric products.
- Dropper Calibration Verification: Per-squeeze volume confirmed within tolerance.
- Certificate of Analysis (COA): Issued with every B2B batch.
Pan-India Supply & Contract Manufacturing
Safety Profile & Precautions
- Hepatotoxicity Risk: Severe hepatic necrosis with overdose. Strict adherence to weight-based dosing (maximum 60 mg/kg/day) is mandatory. Concurrent use of other paracetamol-containing products must be avoided.
- Contraindications: Known hypersensitivity to paracetamol or any excipient. Severe hepatic impairment.
- Precautions: Use in neonates requires physician supervision with extended dosing intervals.
For third-party manufacturing enquiries, private-label contracts, or to request pricing and packaging options for Paracetamol Oral Drops, please use the B2B enquiry form below.
Pan-India Supply & Contract Manufacturing
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?
What is the difference between the 100mg and 150mg strengths?
What is the recommended dosing protocol for Paracetamol Drops?
What are the key safety precautions for Paracetamol Drops?
Is this formulation suitable for neonates?
B2B Manufacturing Guide for Paracetamol Oral Drops
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.


