How to Source N-ACETYLCYSTEINE,ACEBROPHYLLINE for Pharmaceutical Formulation
N-ACETYLCYSTEINE,ACEBROPHYLLINE (Tablets, 600mg, 100 mg) is classified under Respiratory Disorder. This guide highlights key sourcing factors buyers should consider when procuring high-quality N-ACETYLCYSTEINE,ACEBROPHYLLINE for formulation, R&D, or bulk manufacturing.
Product Overview: Tablet is a combination medication containing N-Acetylcysteine 600mg and Acebrophylline 100mg. It is used to treat swelling, blockage, irritation and chest congestion associated with conditions such as chronic obstructive pulmonary disease (chronic emphysema), acute bronchopulmonary diseases (pneumonia, bronchitis, tracheobronchitis), bronchial asthma, atelectasis due to mucus obstruction, and pulmonary complications of cystic fibrosis (genetic disorder mostly affecting lungs).
1. Regulatory Compliance & Documentation
Ensure suppliers provide:
- ✔ Valid DMF (Drug Master File)
- ✔ COA (Certificate of Analysis) for each batch
- ✔ GMP, ISO, or ICH Q7 compliance certificates
2. Purity, Grade & Specification Matching
N-ACETYLCYSTEINE,ACEBROPHYLLINE must meet exact grade and purity for your dosage form:
- ✔ USP / EP / JP grade verification
- ✔ Particle size distribution check
- ✔ Residual solvent and heavy metal limits
3. Supplier Reliability & Audit History
- ✔ Positive past audit reports
- ✔ Pharma client references
- ✔ Years of proven API manufacturing experience
4. Commercial Terms: Pricing, MOQ & Flexibility
- ✔ Transparent pricing
- ✔ Pilot batch MOQ flexibility
- ✔ Volume-based discounts
5. Lead Time, Inventory & Logistics
Typical lead time for N-ACETYLCYSTEINE,ACEBROPHYLLINE is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Conclusion
Sourcing N-ACETYLCYSTEINE,ACEBROPHYLLINE is more than procurement—it’s a strategic partnership. With its tablets form and 600mg, 100 mg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.
Next Step: Get expert assistance in sourcing N-ACETYLCYSTEINE,ACEBROPHYLLINE.
Frequently Asked Questions For Sourcing of N-ACETYLCYSTEINE,ACEBROPHYLLINE
What is the typical lead time for N-ACETYLCYSTEINE,ACEBROPHYLLINE?
Lead times range from 4–6 weeks depending on supplier and region.
Is N-ACETYLCYSTEINE,ACEBROPHYLLINE available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does N-ACETYLCYSTEINE,ACEBROPHYLLINE require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for N-ACETYLCYSTEINE,ACEBROPHYLLINE?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of N-ACETYLCYSTEINE,ACEBROPHYLLINE?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for N-ACETYLCYSTEINE,ACEBROPHYLLINE?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is N-ACETYLCYSTEINE,ACEBROPHYLLINE suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can N-ACETYLCYSTEINE,ACEBROPHYLLINE be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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