How to Source Pregabalin Tablet for Pharmaceutical Formulation
Pregabalin Tablet (Extended-Release Tablets, 82.5 mg, 165 mg, 330 mg) is classified under Antipsychotropic Drugs. It is therapeutically aligned with reference brands such as Lyrica(US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Pregabalin Tablet for formulation, R&D, or bulk manufacturing.
Product Overview:
Pregabalin, marketed as Lyrica, is available in capsules, oral solution, and extended-release tablets across US and EU markets. Indicated for neuropathic pain, epilepsy, and anxiety, it offers consistent demand. An essential listing for CNS-focused pharma B2B platforms aiming for global regulated markets.
Pregabalin is an antiepileptic and neuropathic pain agent approved for conditions like fibromyalgia,...
Pregabalin Tablet API – ideal for compliant pharmaceutical formulation.
Quick Insight: Over 60% of formulation delays are linked to poor API sourcing. A well-planned sourcing strategy can reduce risk and accelerate market entry.
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
Pregabalin Tablet 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 Pregabalin Tablet is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Pro Tip: Engage supplier formulation experts early — it can improve bioavailability and cut development time.
Conclusion
Sourcing Pregabalin Tablet is more than procurement—it’s a strategic partnership. With its extended-release tablets form and 82.5 mg, 165 mg, 330 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 Pregabalin Tablet.
Request a Quote
Frequently Asked Questions For Sourcing of Pregabalin Tablet
What is the typical lead time for Pregabalin Tablet?
Lead times range from 4–6 weeks depending on supplier and region.
Is Pregabalin Tablet available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Pregabalin Tablet require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Pregabalin Tablet?
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 Pregabalin Tablet?
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 Pregabalin Tablet?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Pregabalin Tablet suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Pregabalin Tablet be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
This website uses cookies to ensure you get the best experience. By using our site, you agree to our
Privacy Policy.