Tramadol Hydrochloride and Acetaminophen Tablets 37.5mg+325mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Tramadol Hydrochloride and Acetaminophen Tablets USP (37.5mg+325mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tramadol Hydrochloride and Acetaminophen Tablets USP (37.5mg+325mg)
Each film-coated tablet contains:
Acetaminophen USP………………………325mg
Tramadol Hydrochloride USP………….37.5mg
Excipients……………………………………q.s
Colour: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Tramadol and acetaminophen combination is used to relieve acute pain severe enough to require an opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. When used together, the combination provides better pain relief than either medicine used alone.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
dispense in tight container with child resistant closure.
Tramadol Hydrochloride should be used for severe acute pain only for a period not exceeding 5 days.

Warning: PRESCRIPTION DRUG CAUTION- It is dangerous to take this preparation except in accordance with the medical advice.

 NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

Taking more than daily dose may cause serious liver damage or allergic reactions (e.g. swelling of the face, mouth and throat, difficulty in breathing, itching or rash); in case of overdose, get medical help right away. Quick medical attention is critical even if you do not notice any sign or symptoms.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician

Attach dispensing label as per end country..

Introduction to Tramadol Hydrochloride and Acetaminophen Tablets 37.5mg+325mg

Tramadol Hydrochloride and Acetaminophen Tablets 37.5mg+325mg are a combination analgesic formulation widely used for moderate to severe pain. This fixed-dose combination includes:

• Tramadol Hydrochloride 37.5 mg – an opioid analgesic that blocks pain signals transmitted to the brain

• Acetaminophen (Paracetamol) 325 mg – a non-opioid pain reliever that reduces the release of pain-causing chemical messengers

Together, they offer enhanced pain control compared to either drug used alone, making them one of the most preferred formulations for acute pain, postoperative pain, injury-related pain, and chronic moderate pain.

Globally, the demand for Tramadol Hydrochloride and Acetaminophen Tablets 37.5mg+325mg has been rising due to:

• Growing prevalence of chronic pain

• Need for effective but safer opioid alternatives

• Increased demand in Africa, Latin America, CIS, and Southeast Asia

• Rising hospital and pharmacy usage

As the leading Tramadol Hydrochloride and Acetaminophen Tablets 37.5mg+325mg Manufacturer in India, Taj Pharma consistently meets this global demand with premium-quality, WHO-GMP–approved production standards.

Why Taj Pharma Is the Leading Tramadol Hydrochloride and Acetaminophen Tablets 37.5mg+325mg Manufacturer in India

Taj Pharma is a well-recognized and trusted manufacturer, supplier, and exporter of Tramadol Hydrochloride and Acetaminophen Tablets 37.5mg+325mg from Vapi, Gujarat, India. The company is known for:

• High-quality raw materials

• Stringent quality control

• Advanced production technologies

• Competitive global pricing

• Reliable, bulk, and PAN-India distribution

The company assures high purity, safety, and consistent efficacy in every batch.

This combination is widely used for:

• Acute moderate to severe pain

• Pain that requires opioid-level control

• Pain unresponsive to mild analgesics

• Injury and trauma-based pain

Pharmacology & Benefits

How Tramadol Works

Tramadol is a centrally acting opioid analgesic that blocks the transmission of pain signals to the brain and enhances serotonin/norepinephrine release, reducing pain perception.

How Acetaminophen Works

Acetaminophen blocks prostaglandin synthesis and lowers fever, offering additional pain relief without opioid-like side effects.

Key Benefits of the Combination

• More powerful pain control compared to monotherapy

• Faster onset of action

• Controlled opioid strength

• Fewer opioid-related adverse effects

• Widely accepted globally

Common Side Effects

As a globally accepted formulation, commonly reported side effects include:

Nausea, vomiting, constipation, dizziness, dryness in mouth, sleepiness, diarrhea, abdominal pain, dyspepsia, flatulence, headache, trembling, anxiety, sleep disorder, itching.

In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Offered by Taj Pharma

International buyers receive complete regulatory and export documentation, including:

• WHO-GMP certificate

• EU-GMP (on request for tender markets)

• Certificate of Pharmaceutical Product (COPP)

• CTD / ACTD Dossier (Modules 1–5)

• Manufacturing license

• Stability data (ICH guidelines)

• Batch manufacturing & CoA

• Free Sale Certificate

• DMF support (where applicable)

Custom Packaging & Labeling

Taj Pharma provides fully customizable export-oriented packaging:

• Blister packs / Alu-Alu / Alu-PVC

• Per-country labeling

• Multilingual pack inserts

• Hospital bulk packs

• Child-resistant packaging

• Export-grade cartons & shipper boxes

Shelf-Life, Storage & Dosage Form

• Shelf life: 24–36 months

• Storage: Below 25°C, dry and cool environment

• Dosage form: Film-coated Tablets

• Pack size: Customized per regulatory needs

Export Certifications

Taj Pharma supports global regulatory compliance with:

• WHO-GMP certification

• GLP compliance

• ISO 9001:2015 certification

• Stability studies (zone II/IV)

• COA (Certificate of Analysis)

• MOH approvals for specific markets

Target Countries & Export Markets

Taj Pharma exports globally to:

Africa, Middle East, Latin America, CIS, Southeast Asia, South Asia, Caribbean Islands, Eastern Europe.

Top markets include:
Nigeria, Kenya, Vietnam, Myanmar, Philippines, UAE, Iraq, Yemen, Afghanistan, Sri Lanka, Kazakhstan, Peru, Bolivia, Ecuador, Sudan, Tanzania, Ghana, Haiti, and Ethiopia.

Why Taj Pharma Is the Most Trusted Global Supplier

State-of-the-Art Manufacturing Facilities

• WHO-GMP compliant

• Automated tableting lines

• HEPA-filtered manufacturing zones

• Microbiology testing lab

• Stability chambers for zone IV climates

Affordable Pricing & Bulk Manufacturing

Taj Pharma offers highly competitive prices for:

• Government tenders

• Hospital bulk supply

• Private-label manufacturing

• Contract manufacturing (OEM)

Strong Global Pharmaceutical Presence

• 40+ countries served

• 5,000+ distributors worldwide

• 20+ product registrations annually

• Dedicated export team for documentation

Top 20 Countries 

Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia

Technical Product Specification Table

Call to Action for Distributors & Global Buyers

Are you searching for a trusted Tramadol Hydrochloride and Acetaminophen Tablets 37.5mg+325mg Manufacturer in India?

Do you require WHO-GMP quality, competitive pricing, or private-label production?

Taj Pharma is your ideal partner for:

• Bulk manufacturing

• Contract manufacturing

• Global export supply

• Tender supplies

• PCD pharma franchise opportunities

📩 Contact Taj Pharma Today
Visit: www.tajpharma.com
Email:  info@tajpharma.com
Phone:  +91 84484 44095 (Gen. Enq. 01)

Top 20 FAQs  

1. What are Tramadol Hydrochloride and Acetaminophen Tablets used for?

They are used for moderate to severe pain requiring combination analgesic therapy.

2. Is Taj Pharma a WHO-GMP certified manufacturer?

Yes, Taj Pharma is a certified WHO-GMP manufacturer in India.

3. Can international buyers request custom packaging?

Yes, fully customizable packaging is available.

4. What is the usual shelf life?

24 to 36 months depending on market requirements.

5. Is Tramadol a controlled substance?

Regulations vary by country; importers must check local laws.

6. Does Taj Pharma provide export documents?

Yes, including CTD dossiers, COA, COPP, and more.

7. What is the minimum export order quantity?

Typically 50,000–100,000 tablets, but negotiable.

8. Can Taj Pharma manufacture under private labels?

Yes, OEM and private-label services are available.

9. Does Taj Pharma export to Africa?

Yes, extensively across East, West, and Central Africa.

10. What dosage forms are available?

Film-coated tablets in blister or Alu-Alu packs.

11. Is the product suitable for tenders?

Yes, widely supplied in international healthcare tenders.

12. Are stability data provided?

Yes, ICH stability studies are available.

13. What are common side effects?

Nausea, dizziness, constipation, sleepiness.

14. Do you provide free samples?

Samples can be shared for regulatory or quality evaluation.

15. What global markets do you supply?

Asia, Africa, CIS, Latin America, Middle East.

16. What is the lead time for export orders?

Typically 3–5 weeks.

17. Do you support product registration?

Yes, complete technical documentation is provided.

18. Can distributors request bulk pricing?

Yes, large quantity discounts are available.

19. Are the tablets safe?

Yes, manufactured under WHO-GMP with strict QC.

20. Why choose Taj Pharma?

Quality, affordability, global reach, and regulatory compliance.