Taj Pharma India Ltd. offers a well-defined portfolio of USA-focused pharmaceutical and OTC products, developed in compliance with international quality standards and aligned with US market requirements. Our USA product range primarily covers analgesics, cold & cough combinations, antihistamines, gastrointestinal agents, laxatives, NSAIDs, and anthelmintics, supplied in bulk, retail-ready, and customized private-label packings.
With WHO-GMP, PIC/S, ISO 9001:2018, and GLP-compliant manufacturing facilities, Taj Pharma is strategically positioned to support OTC and Rx supply chains in the United States through reliable, scalable, and regulatory-oriented production.
| Generic Name | Dosage Form | Packing | Available Strengths | Shelf-Life (Months) | Therapeutic Category | BCS Class (Estimate) |
|---|---|---|---|---|---|---|
| Diphenhydramine HCl | Tablets | Bulk Pack of 5000 / 10000 Tablets | 25 mg | 36 | Antihistamine / Sleep Aid | Class I |
| Acetaminophen | Tablets | Bulk Pack of 5000 / 10000 Tablets | 500 mg | 36 | Analgesic / Antipyretic | Class I |
| Acetaminophen + Aspirin + Caffeine | Tablets | Bulk Pack of 5000 / 10000 Tablets | 250 mg + 250 mg + 65 mg | 24 | Analgesic Combination | Class I |
| Acetaminophen + Diphenhydramine HCl | Tablets | Bulk Pack of 5000 / 10000 Tablets | 500 mg + 25 mg | 36 | Analgesic / Night-time Cold Relief | Class I |
| Acetaminophen + Chlorpheniramine Maleate + Dextromethorphan HBr | Tablets | Bulk Pack of 5000 / 10000 Tablets | 500 mg + 2 mg + 15 mg | 36 | Cold & Cough Combination | Class I |
| Aspirin (Chewable) | Tablets | Bulk Pack of 5000 / 10000 Tablets | 81 mg | 24 | Antiplatelet / Analgesic | Class I |
| Aspirin (Enteric Coated) | Tablets | Bulk Pack of 5000 / 10000 Tablets | 81 mg | 24 | Antiplatelet / Cardiovascular | Class II |
| Acetaminophen + Dextromethorphan HBr + Guaifenesin + Phenylephrine HCl | Tablets | 72 Pouch of 2 Tabs & 6 Pouch of 2 Tabs | 325 mg + 15 mg + 200 mg + 5 mg | 36 | Cold, Cough & Flu Relief | Class I |
| Acetaminophen + Chlorpheniramine Maleate + Phenylephrine HCl | Tablets | 72 Pouch of 2 Tabs & 6 Pouch of 2 Tabs | 325 mg + 2 mg + 5 mg | 36 | Cold & Allergy Relief | Class I |
| Acetaminophen + Dextromethorphan HBr + Phenylephrine HCl | Powder / Granules | Box of 6 Sachets (10 g) | 650 mg + 20 mg + 10 mg | 24 | Cold & Flu Relief | Class I |
| Acetaminophen + Diphenhydramine HCl + Phenylephrine HCl | Powder / Granules | Box of 6 Sachets (10 g) | 650 mg + 25 mg + 10 mg | 24 | Night-time Cold Relief | Class I |
| Diclofenac | Tablets | Box of 1 Strip of 10 Tablets | 100 mg | 24 | NSAID / Anti-inflammatory | Class II |
| Guaifenesin | Tablets | Bulk Pack of 5000 / 10000 Tablets | 400 mg | 24 | Expectorant | Class I |
| Pyrantel Pamoate | Tablets | Box of 1 Blister of 10 Tablets | 180 mg | 36 | Anthelmintic | Class III |
| Sennosides (Coated) | Tablets | Bulk Pack of 5000 / 10000 Tablets | 8.6 mg | 36 | Laxative | Class III |
| Sennosides (Coated) | Tablets | Bulk Pack of 5000 / 10000 Tablets | 12 mg | 36 | Laxative | Class III |
| Sennosides (Natural) | Tablets | Bulk Pack of 5000 / 10000 Tablets | 8.6 mg | 36 | Herbal Laxative | Class III |
Structured USA Product Portfolio
The Taj Pharma USA product list is developed using a structured, buyer-friendly format, ensuring transparency and regulatory clarity. Each product is defined by:
- Generic Name
- Dosage Form
- Packing Configuration
- Available Strengths
- Shelf-Life (24–36 months)
- Therapeutic Category
- Estimated BCS Classification
This structured approach simplifies:
- ANDA / OTC monograph assessments
- Bio-waiver feasibility evaluation
- Private-label and bulk procurement decisions
- Regulatory and pharmacokinetic discussions
Key Therapeutic Segments for the US Market
1. Analgesics & Antipyretics
- Acetaminophen (single & combination products)
- Aspirin (chewable and enteric-coated)
- Diclofenac tablets
These products address pain management, fever control, and cardiovascular support, with strengths and dosage forms aligned to US OTC and prescription usage.
2. Cold, Cough & Flu Combinations
- Acetaminophen + Dextromethorphan + Guaifenesin + Phenylephrine
- Acetaminophen + Chlorpheniramine + Phenylephrine
- Night-time cold relief combinations with Diphenhydramine
- Sachet-based granule formulations for rapid symptom relief
These combinations are designed for high-volume seasonal demand, offered in bulk packs, pouch packs, and sachet formats suitable for retail or institutional supply.
3. Antihistamines & Sleep Aids
- Diphenhydramine HCl tablets
- Combination night-time cold products
Widely accepted in the US OTC market, these products comply with USP-grade formulation expectations and long shelf-life requirements.
4. Gastrointestinal & Supportive Care
- Guaifenesin tablets (expectorant)
- Pyrantel Pamoate tablets (anthelmintic)
- Sennosides (coated and natural) tablets
These products support digestive health, parasitic infection management, and bowel regulation, with strengths commonly accepted in the US market.
BCS-Oriented Product Strategy
Most Taj Pharma USA products fall under BCS Class I and Class III, offering advantages such as:
- Higher probability of bio-waiver eligibility
- Simplified regulatory pathways
- Faster development timelines
- Cost-efficient ANDA or OTC compliance strategies
This positions Taj Pharma as a regulatory-savvy manufacturing partner rather than only a contract supplier.
Packaging & Supply Flexibility
Taj Pharma supports multiple supply models for the US market:
- Bulk Packs: 5,000 / 10,000 tablets for repackers and private labels
- Retail-Ready Packs: Blister strips, pouches, sachet boxes
- Customized Packing: As per US distributor or brand owner specifications
All packaging is designed to meet stability, labeling, and logistics requirements for international shipment.
Quality & Compliance Assurance
- WHO-cGMP compliant manufacturing
- PIC/S aligned quality systems
- Stability-validated shelf life (24–36 months)
- Batch traceability and documentation readiness
- Export-oriented QA/QC and regulatory support
Supply Capability to the USA
Taj Pharma is capable of supplying to the United States under:
- Bulk pharmaceutical supply
- OTC monograph-based products
- Private-label manufacturing
- Long-term supply agreements
Our manufacturing scale, documentation readiness, and regulatory understanding allow us to support consistent, long-term partnerships with US importers and marketers.
Taj Pharma’s USA product portfolio represents a strategically structured, regulation-ready, and commercially viable offering for the US pharmaceutical and OTC markets. With a strong focus on quality, compliance, shelf-life stability, and supply flexibility, Taj Pharma stands as a reliable Indian manufacturing partner for the United States.
