How to Source Aripiprazole Injection for Pharmaceutical Formulation

Aripiprazole Injection (Intramuscular (IM) Injection, Short-acting: 9.75 mg/1.3 mL; Long-acting: 300 mg, 400 mg (monthly)) is classified under Antipsychotropic Drugs. It is therapeutically aligned with reference brands such as Abilify(EU & US). This guide highlights key sourcing factors buyers should consider when procuring high-quality Aripiprazole Injection for formulation, R&D, or bulk manufacturing.

Product Overview: Aripiprazole, marketed as Abilify, is a widely used antipsychotic available in oral and injectable forms across the US and EU. Offered in strengths from 2 mg to 400 mg, it supports schizophrenia and bipolar treatment. Pharma buyers source aripiprazole in bulk from certified suppliers for mental health distribution channels. Aripiprazole is an atypical antipsychotic used to treat schizophrenia, bipolar disorder, depression...

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

Aripiprazole Injection 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 Aripiprazole Injection 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 Aripiprazole Injection is more than procurement—it’s a strategic partnership. With its intramuscular (im) injection form and Short-acting: 9.75 mg/1.3 mL; Long-acting: 300 mg, 400 mg (monthly) 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.

Frequently Asked Questions For Sourcing of Aripiprazole Injection