Promethazine Hydrochloride Tablets 25mg

Promethazine Hydrochloride tablets 25mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Promethazine Hydrochloride tablets USP 12.5mg
2. Promethazine Hydrochloride tablets USP 25mg
3. Promethazine Hydrochloride tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Promethazine Hydrochloride tablets USP 12.5mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………12.5mg
Excipients…………………………………………………….q.s
Colour: Sunset yellow FCF

2. Promethazine Hydrochloride tablets USP 25mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………25mg
Excipients………………………………………………….q.s
Colour: Sunset yellow

3. Promethazine Hydrochloride tablets USP 50mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………50mg
Excipients…………………………………………………..q.s
Colour: Sunset yellow lake

THERAPEUTIC INDICATIONS:

Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.

Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician.

Attach dispensing label as per end country.

Introduction to Promethazine Hydrochloride Tablets 25mg

Promethazine Hydrochloride is a first-generation antihistamine belonging to the phenothiazine class. Promethazine Hydrochloride Tablets 25mg are widely used for:

• Treatment of nausea and vomiting

• Relief from vertigo and motion sickness

• Allergic conditions such as hay fever, urticaria, and rhinitis

• Appetite stimulation

• Managing morning sickness

• Sedation in children above 5 years

• Short-term treatment of insomnia in adults

Promethazine works by blocking histamine (H1) receptors, thereby reducing allergy symptoms. Additionally, it has a direct action on brain centers involved in nausea and vomiting, delivering strong antiemetic effects.

Why Global Demand Continues to Grow

The global requirement for Promethazine Hydrochloride Tablets 25mg has increased due to:

1. Rising incidences of allergy-related conditions

2. High global supply needs in emergency and hospital settings

3. Increased demand in Southeast Asia, Africa, Middle East, and Latin America

4. Growing preference for cost-effective Indian pharmaceutical exports

Taj Pharma caters to this demand with unmatched quality, stable supply, and competitive pricing.

 Complete Export Guide for Buyers & Importers  

Global buyers prefer Taj Pharma because the company provides complete regulatory support, international-grade packaging, and end-to-end export logistics.

 Regulatory Documentation Provided

Taj Pharma offers a full regulatory documentation dossier, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• CTD/ACTD Dossier

• Stability Data (Zone II, III & IV)

• FDA/ISO compliant manufacturing documentation

• Batch Manufacturing Records & COA

• MSDS, COA, MOA

• Analytical validation and bioequivalence support (where required)

These documents ensure quick product registration in:

• Africa

• Southeast Asia

• LATAM

• CIS

• Middle East

• EU-adjacent markets

 Packaging & Labeling Options for Global Buyers

Taj Pharma provides custom, country-specific packaging such as:

• Blister packs (Alu-Alu / PVC-Blister)

• Bottle packs

• Hospital bulk packs

• Multi-lingual printed cartons

• Customized artwork in English, French, Spanish, Arabic, Russian, Swahili, Portuguese, etc.

All packaging meets stability and safety standards for long-distance shipping.

 Shelf-Life, Storage & Dosage Form

  Export Certifications

Taj Pharma is fully certified with:

• WHO-GMP

• EU-GMP equivalent systems

• ISO 9001:2015 & ISO 14001

• GLP-compliant labs

• COPP for multiple countries

These certifications ensure global acceptance and compliance with regulatory norms.

 Top Target Export Markets

Taj Pharma exports Promethazine Hydrochloride Tablets 25mg to:

• Nigeria

• Kenya

• South Africa

• Ethiopia

• Ghana

• Uganda

• Bangladesh

• Vietnam

• Philippines

• Yemen

• Iraq

• Afghanistan

• Myanmar

• Peru

• Bolivia

• Dominican Republic

• Haiti

• Kazakhstan

• Uzbekistan

• Sri Lanka

 Why Taj Pharma Is the Most Trusted Manufacturer, Supplier & Exporter of Promethazine Hydrochloride Tablets 25mg

Taj Pharma’s leadership is built on innovation, regulatory excellence, and consistent quality.

  1. State-of-the-Art Manufacturing

Taj Pharma operates advanced WHO-GMP facilities featuring:

• High-speed tablet manufacturing lines

• Fully automated granulation, compression & coating

• In-house R&D and QC laboratories

• Controlled environment for sensitive antihistamine drug production

 2. Affordable Pricing with World-Class Quality

Global buyers benefit from:

• Economical bulk order rates

• Guaranteed supply consistency

• Transparent pricing policy

• Zero compromise on quality

Taj Pharma’s value-driven pricing makes it the preferred choice for governments, NGOs, and private importers.

  3. Worldwide Presence & Reliable Supply Chain

Taj Pharma maintains:

• Export network in 42+ countries

• Dedicated international documentation team

• Swift handling of customs, freight, and delivery

• Support for tender participation

The company is known for on-time deliveries, even in high-volume orders.

 Top 20 Countries  

India | Vietnam | UAE | Saudi Arabia | Kenya | Tanzania | Nigeria | Philippines | Cambodia | Ghana | Peru | Colombia | Uzbekistan | Kazakhstan | Sri Lanka | Myanmar | Yemen | Oman | South Africa | Chile

 Technical Product Specification Table

  Call to Action  

If you are a pharmaceutical distributor, importer, tender participant, or PCD franchise seeker, Taj Pharma is your ideal partner for Promethazine Hydrochloride Tablets 25mg.

📩 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📦 Bulk Exports | Third-Party Manufacturing | PCD Franchise
Taj Pharma guarantees unmatched quality, compliance, and global supply capabilities.

 Top 20 FAQs  

1. What is Promethazine Hydrochloride Tablets 25mg used for?

Allergy relief, nausea, vomiting, vertigo, insomnia, and motion sickness.

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

Yes, Taj Pharma manufactures under WHO-GMP, ISO, and international guidelines.

3. Does Taj Pharma export Promethazine Tablets?

Yes, to over 42+ countries.

4. Is customized packaging available?

Yes, including multi-lingual artwork.

5. What is the shelf life?

24–36 months.

6. What certifications are provided for registration?

COPP, CTD dossiers, GMP, COA, stability data, etc.

7. Is Promethazine safe for children?

Yes, for children above 5 years (as prescribed by a physician).

8. Can Taj Pharma supply bulk quantities?

Absolutely. Large-scale production ensures consistent supply.

9. Are promotional materials available for PCD franchise?

Yes, marketing materials are available.

10. What markets does Taj Pharma supply to?

Africa, Asia, LATAM, Middle East, CIS.

11. Is the product available in Alu-Alu packaging?

Yes.

12. How does Promethazine work?

It blocks histamine and affects brain centers controlling nausea.

13. Does it cause drowsiness?

Yes, it may cause sleepiness.

14. Should alcohol be avoided?

Yes, alcohol increases drowsiness.

15. Is artwork approved before printing?

Yes, buyers confirm final design.

16. Is freight support provided?

Yes, Taj Pharma handles sea and air shipments.

17. Can it be used for insomnia?

Yes, for short-term insomnia treatment.

18. What pharmacopoeias are available?

IP, BP & USP grades.

19. Do you support product registration?

Yes, full documentation is provided.

20. Why choose Taj Pharma?

Quality, affordability, regulatory compliance, and global trust.