99% Citicoline API Of GMP Factory

Q1: What regulatory documentation do you provide to support our drug application?

We provide an extensive information package tailored for regulatory submissions. This includes the Drug Master File (DMF) number for reference in your applications, a detailed Certificate of Analysis (CoA) for each batch, stability study data, and a comprehensive validation report. For compounding pharmacies, we supply all documentation required by boards of pharmacy to validate the quality and source of your API.

Q2: How do you ensure quality control and batch-to-batch consistency?

The quality of our citicoline is embedded in our process. We operate under a quality management system certified for ICH Q7 GMP. Every batch undergoes rigorous in-process and final release testing against strict pharmacopoeial standards. Our state-of-the-art analytics lab uses HPLC, GC, and ICP-MS to verify identity, purity, potency, and the absence of unwanted impurities. You receive a complete analytical profile with every shipment.

Q3: Our pharmacy is looking to compound with Citicoline. Is your API suitable, and what are the key considerations for handling?

Absolutely. Our high-purity Citicoline bulk powder is ideal for non-sterile compounding of oral solids and liquids. Crucially, pharmacists must conduct a documented risk assessment before each compounding activity. Key considerations for Citicoline include:

• Stability: It is hygroscopic. Store in a tightly sealed container in a cool, dry place.

• Trituration: For tiny doses, accurate trituration with a suitable diluent is essential to avoid calculation and measurement errors, which are common sources of potency issues in compounding.

Q4: Can we import your API internationally? What are the requirements?

Yes, we regularly ship globally. The specific requirements depend on the destination country’s health authority regulations. For example, in Canada, a pharmacy may import an API if it is “not commercially available” from a licensed Canadian supplier, often applicable during shortages or for specific unmarketed compounds. It is the importer’s responsibility to verify the API’s status and ensure it is sourced from a reliable, licensed entity. We assist by providing all necessary export certificates, GMP statements, and commercial invoices.

Q5: What is your lead time, and what order quantities do you offer?

We offer flexible scalability from R&D quantities (grams/kilograms) to complete commercial bulk volumes (multi-ton). Standard lead times for commercial quantities are 8-10 weeks, with expedited options available. We encourage you to share your forecast to ensure seamless inventory planning.

Q6: How do you manage supply chain continuity and raw material sourcing?

We mitigate supply chain risk through dual sourcing of key raw materials and by maintaining strategic safety stock. Our procurement team continuously monitors the global raw material landscape. We are transparent about potential disruptions and work actively with partners to find solutions.

Q7: Do you have food-grade citicoline bulk powder for nutritional supplements?

Yes, we have food-grade citicoline in bulk, ISO-certified for use in nutritional products, and the unit price is lower than that of pharma-grade citicoline. Contact us for a quick comparison.