GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Ambroxol HCl I.P.…………………………….300mg
N-Acetylcysteine USP……………………………200mg
Excipients…………………………………. q.s.
Colours: Quinoline Yellow
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Ambroxol HCl+N-Acetylcysteine Tablet 300mg+200mg Technical Specification:
| Product Name: |
Ambroxol HCl+N-Acetylcysteine Tablet |
| Brand Name: | Generics |
| Strength: | (300mg+200mg) |
| Dosage Form: | Tablet (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Expectorant |
| Indication: | Acetylcysteine+Ambroxol is used to prevent chronic obstructive pulmonary disease. Acetylcysteine + Ambroxol is a combination of two mucolytic medicines: Acetylcysteine and ambroxol. It thins and loosens mucus (phlegm) making it easier to cough out. |
| Storage: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ambroxol HCl+N-Acetylcysteine Tablet 300mg+200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ambroxol HCl+N-Acetylcysteine Tablet 300mg+200mg
Each Film-coated tablet contains:
Ambroxol HCl I.P.…………………………….300mg
N-Acetylcysteine USP……………………………200mg
Excipients…………………………………. q.s.
Colours: Quinoline Yellow
THERAPEUTIC INDICATIONS:
- Acetylcysteine+Ambroxol is used to prevent chronic obstructive pulmonary disease. Acetylcysteine + Ambroxol is a combination of two mucolytic medicines: Acetylcysteine and ambroxol. It thins and loosens mucus (phlegm) making it easier to cough out. </br>
CAUTION & WARNING:
- CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug-Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
- Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
- Dosage: As directed by the Physician.
Introduction to Ambroxol HCl+N-Acetylcysteine Tablet 300mg+200mg
Ambroxol HCl+N-Acetylcysteine Tablet 300mg+200mg is a widely prescribed respiratory medicine used in the management of chronic and acute respiratory diseases where mucus overproduction and difficulty in expectoration occur.
-
Ambroxol HCl: A mucolytic agent that thins mucus and eases airway clearance.
-
N-Acetylcysteine (NAC): A powerful antioxidant and mucolytic that breaks disulfide bonds in mucus, making it less viscous.
This fixed-dose combination is prescribed for patients with bronchitis, COPD, asthma, cystic fibrosis, and other pulmonary disorders. The global demand for Ambroxol HCl+N-Acetylcysteine Tablet 300mg+200mg has been increasing due to rising incidences of respiratory conditions and a growing need for effective mucolytic therapy.
Taj Pharma, based in Vapi, Gujarat, India, stands out as a leading manufacturer, supplier, and exporter of this formulation, delivering superior quality pharmaceuticals to global buyers.
In-Depth Details for Importers, Exporters & Buyers
Regulatory Documentation Provided
Taj Pharma ensures complete compliance with international regulatory frameworks. Buyers receive:
-
WHO-GMP Certificate
-
EU-GMP Approval (for select markets)
-
Certificate of Pharmaceutical Product (COPP)
-
Common Technical Document (CTD) Dossier
-
Stability Data
-
Free Sale Certificate (FSC)
Custom Packaging & Labeling
-
Blister packs / Alu-Alu / Strip packaging
-
Customized branding available for distributors & franchise partners
-
Multilingual labeling per regulatory requirements
Shelf-Life & Storage
-
Standard shelf-life: 24–36 months
-
Storage: Below 30°C, in a dry place away from direct sunlight
Dosage Form
-
Tablet (300mg Ambroxol + 200mg NAC)
-
Also available in syrup and effervescent formulations (on request).
Export Certifications
-
WHO-GMP Certified Plant
-
ISO 9001:2015 Compliance
-
COPP for multiple regulated markets
-
PIC/S & CTD submission-ready
Target Countries & Export Markets
Taj Pharma exports to 70+ countries, including:
-
Latin America (Peru, Chile, Brazil)
-
CIS Nations (Russia, Ukraine, Kazakhstan)
-
African Nations (Nigeria, Kenya, South Africa)
-
Middle East (UAE, Saudi Arabia, Iraq)
-
South & Southeast Asia (Vietnam, Philippines, Bangladesh)
-
European Markets (Germany, UK under specific dossier submissions)
Why is the Most Trusted Manufacturer, Supplier & Exporter
1. State-of-the-Art Manufacturing
Taj Pharma operates WHO-GMP, EU-GMP-certified facilities in Vapi, Gujarat, India. The plants are equipped with advanced technology ensuring high purity, safety, and efficacy of medicines.
2. Affordable Pricing & Quality Assurance
The company follows stringent quality assurance (QA) and quality control (QC) protocols, providing cost-effective yet premium medicines.
3. Global Presence & Supply Chain Support
Taj Pharma maintains strong supply chains across 70+ countries, ensuring timely delivery of large-scale consignments.
4. Top 20 Export Destinations
Nigeria, Kenya, Ghana, South Africa, Tanzania, Uganda, Philippines, Vietnam, Myanmar, Sri Lanka, Nepal, UAE, Saudi Arabia, Iraq, Yemen, Kazakhstan, Uzbekistan, Peru, Bolivia, Chile
Technical Product Specification
| Parameter | Details |
|---|---|
| Product Name | Ambroxol HCl + N-Acetylcysteine Tablet |
| Strength | 300mg + 200mg |
| Dosage Form | Tablet |
| Packaging | Blister / Alu-Alu / Customized |
| Shelf-Life | 24–36 months |
| Storage | Store below 30°C, dry & dark place |
| Certification | WHO-GMP, EU-GMP, ISO, COPP |
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
| Indications | COPD, Bronchitis, Asthma, Cystic Fibrosis |
| Common Side Effects | Nausea, vomiting, stomach upset, mild fever |
| Availability | Export & PCD Pharma Franchise |
If you are looking for a reliable Ambroxol HCl+N-Acetylcysteine Tablet 300mg+200mg manufacturer in India, Taj Pharma is your trusted partner.
-
Competitive pricing with bulk order support
-
WHO-GMP-certified manufacturing facilities
-
Regulatory documents & dossier support for global markets
-
PAN India PCD Pharma Franchise opportunities
👉 Contact Taj Pharma today to discuss bulk requirements, distributorship, or franchise partnerships.
Top 20 FAQs
1. What is Ambroxol HCl+N-Acetylcysteine Tablet 300mg+200mg used for?
It is used for the treatment of respiratory diseases with abnormal mucus production, including COPD, bronchitis, and asthma.
2. Who manufactures the best Ambroxol HCl+N-Acetylcysteine Tablet 300mg+200mg in India?
Taj Pharma, based in Vapi, Gujarat, is a leading manufacturer and exporter of this formulation.
3. Is the medicine WHO-GMP certified?
Yes, Taj Pharma manufactures under WHO-GMP and ISO certifications.
4. Can distributors get custom packaging?
Yes, Taj Pharma provides custom labeling and multilingual packaging.
5. What is the shelf life of this product?
The standard shelf life is 24–36 months.
6. Are dossiers provided for regulated markets?
Yes, CTD dossiers and regulatory documents are available.
7. What are the side effects?
Mild nausea, vomiting, stomach upset, and fever may occur.
8. Is it available for PCD Pharma Franchise?
Yes, Taj Pharma offers franchise opportunities across India.
9. How should the tablets be stored?
Store below 30°C in a cool, dry place.
10. Is it exported globally?
Yes, Taj Pharma exports to 70+ countries.
11. Can buyers request bulk orders?
Yes, bulk and institutional orders are supported.
12. Does Taj Pharma provide free samples?
Samples are provided to registered importers/distributors under request.
13. Is it suitable for pediatric use?
It may be prescribed for children over 2 years under medical supervision.
14. How does Ambroxol work?
Ambroxol thins mucus and eases its removal from the respiratory tract.
15. How does NAC help?
N-Acetylcysteine liquefies thick mucus and has antioxidant properties.
16. Is it available in other forms?
Yes, syrup and effervescent formulations are available.
17. What certifications does Taj Pharma hold?
WHO-GMP, ISO 9001:2015, COPP, and EU-GMP (for select products).
18. Can it be shipped to the Middle East?
Yes, Taj Pharma exports to UAE, Saudi Arabia, Iraq, and other Gulf countries.
19. Is pricing competitive?
Yes, Taj Pharma offers best-in-industry pricing without compromising on quality.
20. How can I contact Taj Pharma?
Through their official website or corporate office in Vapi, Gujarat, India.






