Letco Medical has a proud history of being a quality leader in the compounding industry.
Letco’s relentless focus on quality makes them the optimal choice for pharmacies: customers can trust their stringent quality control procedures, industry-leading quality assurance programs and unmatched quality record with the FDA.
Letco’s quality systems and processes are designed to comply with current Good Manufacturing Practices (cGMP). Letco requires that all their API manufacturers possess current FDA Drug Establishment Registration. This information is verified to be current at the time of receipt for every order of material placed from a supplier. Letco also verifies there are no FDA Import Alerts on the manufacturer upon receipt.
Letco is registered with both the FDA and DEA, and maintains Verified-Accredited Wholesale Distributors (VAWD) accreditation. Letco maintains licenses with all states in which they do business.
Please note that the majority of compounding ingredients available in Australia are manufactured overseas. As outlined in the Australian Pharmaceutical Formulary and Handbook:
“Overseas manufacturers should hold a certificate of GMP compliance or equivalent accreditation from a regulatory or accrediting authority equivalent to the TGA.”
To demonstrate compliance in Australia, all pharmacists can verify Letco’s current registration status as a repacker and relabeller on the FDA’s Drug Establishment register: https://dps.fda.gov/decrs.
Additionally, for most Active Pharmaceutical Ingredients, Letco indicates the manufacturer’s name on their Certificate of Analysis. Pharmacists can verify, for each individual API, the manufacturer’s registration status on the FDA’s Drug Establishment register: https://dps.fda.gov/decrs. If you need help with this process or with a specific product, please do not hesitate to contact Bella Corp.
As a “regulatory or accrediting authority equivalent to the TGA”, the US Food and Drug Administration conducts worldwide inspections of pharmaceutical manufacturing facilities, including facilities that manufacture active ingredients, to ensure that they comply with current Good Manufacturing Practices (cGMP). The FDA will only list manufacturing facilities that are fully compliant with cGMP.
APIs are sourced only from FDA-registered manufacturers. From the first link in the supply chain to the last, Letco ensures the integrity of their suppliers by fully and rigorously qualifying them and validating quality at product origin. Letco also deploys a proactive supplier audit program that ensures standards are maintained at all times.
The quality of raw materials can vary by manufacturer, supplier, batch and receipt. Letco inspects and maintains the quality of compounding ingredients at every step with rigorous receiving, regulatory verification, product inspection, analytical testing, packaging and holding procedures – including full monograph testing of APIs (on an annual basis as part of the Manufacturer Verification Program) and identification tests on every lot of material received by leading third-party labs to ensure the safest and best quality product every time.
Testing for USP-grade products is fully compliant with all USP requirements. Testing for products of a different grade (EP, JP, FCC, etc.) is fully compliant with the corresponding monograph.
Over 200 procedures and forms govern Letco’s quality systems. Letco’s products are held and distributed under the strictest conditions, with 24/7 electronic temperature and humidity monitoring, temperature mapping, USP storage conditions for all product types, validated cold chain packaging and VAWD accreditation.
Letco’s experienced operators are regularly assessed and are trained annually on rigorous operating procedures to ensure continuous delivery of superior quality in all aspects of their work.
Bella Corp Trading is a wholesaler and distributor of raw ingredients and supplies to compounding pharmacies – suppliers/wholesalers/third-party distributors of raw materials that do not undertake steps in the manufacture of APIs are not required to hold a manufacturing licence issued by the TGA for the supply/wholesale or distribution of raw materials.
Bella Corp Trading Pty Ltd holds a Licence to Import from the Australian Government Office of Drug Control, and a Wholesale Licence for Medicines (schedule 2, 3, 4 & 8) issued by Queensland Health. We are regularly audited by Queensland Health and have consistently met all compliance requirements. Our licence documentation is available upon request.
All stock is received and shipped according to the strictest guidelines, to maintain the quality of our products. Our premises are temperature-monitored at all times. Cold-chain medicines are stored within the recommended temperature range and strictly monitored to ensure the integrity of the product is maintained.
Please do not hesitate to contact us at bellacorp@bellacorp.com.au if you have any questions!
Guidelines on compounding of medicines, Pharmacy Board of Australia, October 2024 Edition
Australian Pharmaceutical Formulary and Handbook, 26th Edition
US Code of Federal Regulations Title 21, Part 210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General.
Facts About the Current Good Manufacturing Practice (CGMP), US Food and Drug Administration – https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practice-cgmp
