FIVEO1 DEPARTMENT 69 BILL Pharmaceutical API Exportation @2026-10-12 11:51:23 - Calle 15 de Febrero
Calle 15 de Febrero |
1. PURPOSE AND PARTIES
This bill and contract makes Fiveo1 a contracted supplier to US government agencies of off-patent Active Pharmaceutical Ingredients (APIs) sourced from licensed manufacturers in Mexico, Brazil, Argentina, Colombia and Guatemala.
Supplier: Fiveo1, PO Box 312786, Avalon, California 90704 (Santa Catalina Island), represented by Evan Winter
Buyer: The US government agency named in the final contract
Scope: Purchase, import and delivery of the APIs in the schedule below, under Department 69
2. REGIONAL API PRODUCTION BACKGROUND
The production of Active Pharmaceutical Ingredients (APIs) in Central and South America is a strategically vital but structurally constrained segment of the global pharmaceutical supply chain. While the region has significant manufacturing capabilities for finished dosage forms, its capacity to produce the fundamental chemicals—the APIs themselves—is limited and heavily dependent on imports, primarily from Asia. The most fundamentally used chemicals produced or processed in the region can be organized by therapeutic category, with production concentrated in a few key countries.
Antibiotics represent a core category of API production. Mexico is a major producer, with companies like Centrient Pharmaceuticals manufacturing enzymatically produced Amoxicillin and Ampicillin at its facilities. Other antibiotic APIs produced in Mexico include Cephalexin monohydrate, Gentamicin sulfate, and Lincomycin hydrochloride. Chloramphenicol, a broad-spectrum antibiotic first isolated in Venezuela, is now primarily produced by chemical synthesis in the region. In Brazil, Nortec Química has a portfolio of approximately 45 APIs in production, including Benznidazole for Chagas disease and various Benzodiazepines such as Clonazepam and Bromazepam.
Cardiovascular and Central Nervous System (CNS) drugs form another fundamental category. Mexico’s Neolpharma (through its subsidiary NeolSym) produces APIs including Methylphenidate Hydrochloride, Phenytoin, Sodium Phenytoin, Bezafibrate, Diazepam, Nicardipine, and Folic Acid. The company operates three API plants in Mexico and produces 15 types of APIs for CNS conditions and hypertension. In Brazil, Nortec Química produces Bupivacaine, Prilocaine, and Esketamine.
Analgesics and Anti-inflammatories are also produced. Brazil’s API manufacturers produce Ibuprofen, Dexamethasone, Paclitaxel, Fluorouracil, Etoposide, Simvastatin, Prednisone, and Omeprazole. Argentina’s Triquim S.A. produces Remifentanil (an opioid analgesic), Benfotiamine, Bosentan, Imiquimod, and Meglumine Antimoniate.
Biopharmaceuticals constitute a growing segment, particularly in Argentina and Brazil. Argentina has developed capabilities in producing biotech APIs, including Rituximab and Bevacizumab (the first biosimilar monoclonal antibodies in Latin America), as well as first-generation biotech drugs like Interferon, Erythropoietin, and Growth Hormone. Brazil’s Fiocruz is establishing production of the API for Insulin Glargine, which will be the first insulin API production plant in Latin America.
The regional production landscape is marked by significant disparities. Brazil, Argentina, and Mexico are the primary API producers, together accounting for three-quarters of total regional exports. Brazil is the leading representative in global API production, ranking among the top 30 global exporters. However, even Brazil imports approximately 90% of the APIs used by its pharmaceutical industry. Mexico currently manufactures 82 active pharmaceutical ingredients, with companies like TAPI Mexico investing in 5-fluorouracil production for oncology treatments. Colombia has a smaller but growing API sector, with companies like PROQUIMES S.A. manufacturing APIs and mineral salts. In Central America, Guatemala’s Luminova Pharma is a major generic manufacturer with capabilities across antibiotics, cardiovascular, diabetes, and CNS therapeutic areas.
The fundamental chemicals produced in Central and South America are therefore a focused set of off-patent, high-demand molecules across antibiotics, cardiovascular drugs, CNS medications, analgesics, and a growing portfolio of biopharmaceuticals. The region’s API sector remains strategically dependent on imports for the vast majority of its needs, but ongoing investments in Brazil, Mexico, and Argentina signal a gradual push toward greater self-sufficiency in these essential chemical building blocks.
3. PRODUCT SCHEDULE
The schedule covers 38 off-patent APIs in eight classes, each sourced from the country where it is already produced at scale.
Class | APIs | Source
Antibiotics | Amoxicillin, Ampicillin, Cephalexin monohydrate, Gentamicin sulfate, Lincomycin HCl, Chloramphenicol | Mexico
Antiparasitic | Benznidazole, Meglumine antimoniate | Brazil, Argentina
CNS | Methylphenidate HCl, Phenytoin, Sodium phenytoin, Diazepam, Clonazepam, Bromazepam | Mexico, Brazil
Anesthetics and analgesics | Bupivacaine, Prilocaine, Esketamine, Remifentanil, Ibuprofen | Brazil, Argentina
Cardiovascular | Nicardipine, Bezafibrate, Simvastatin, Bosentan | Mexico, Brazil, Argentina
Oncology and steroids | Paclitaxel, Fluorouracil, Etoposide, Dexamethasone, Prednisone | Brazil, Mexico
Other small molecules | Omeprazole, Folic acid, Benfotiamine, Imiquimod | Mexico, Brazil, Argentina
Biologics | Rituximab, Bevacizumab, Interferon, Erythropoietin, Growth hormone, Insulin glargine (planned) | Argentina, Brazil
*Controlled substance.
4. PRICING AND MINIMUM PROFIT
The contract floor price per kg is the lowest known supplier cost, plus 12% for freight, insurance, customs and lot testing, plus a 15% minimum Fiveo1 margin. No sale goes below the floor. Figures are indicative low-end bulk prices in USD per kg, to be replaced by written supplier quotes.
Pricing Formula: Contract Floor = (Lowest Known Cost × 1.12) × 1.15
Landed Cost = Lowest Known Cost × 1.12 | Fiveo1 Minimum Margin = 15%
API | Lowest Known Cost/kg | Landed Cost/kg | Contract Floor/kg
Ibuprofen | $5 | $5.60 | $6.44
Folic acid | $15 | $16.80 | $19.32
Amoxicillin | $25 | $28.00 | $32.20
Ampicillin | $30 | $33.60 | $38.64
Cephalexin | $30 | $33.60 | $38.64
Chloramphenicol | $40 | $44.80 | $51.52
Phenytoin | $40 | $44.80 | $51.52
Gentamicin sulfate | $100 | $112.00 | $128.80
Simvastatin | $100 | $112.00 | $128.80
Lincomycin HCl | $150 | $168.00 | $193.20
Omeprazole | $150 | $168.00 | $193.20
Prednisone | $300 | $336.00 | $386.40
Fluorouracil | $300 | $336.00 | $386.40
Diazepam* | $300 | $336.00 | $386.40
Clonazepam* | $800 | $896.00 | $1,030.40
Bupivacaine | $800 | $896.00 | $1,030.40
Dexamethasone | $1,000 | $1,120.00 | $1,288.00
Methylphenidate* | $2,000 | $2,240.00 | $2,576.00
Etoposide | $3,000 | $3,360.00 | $3,864.00
Paclitaxel | $10,000 | $11,200.00 | $12,880.00
*Controlled substance. Landed cost excludes DEA permit and quota fees.
For every other API in the schedule (Benznidazole, Bromazepam, Prilocaine, Esketamine, Remifentanil, Bezafibrate, Nicardipine, Bosentan, Imiquimod, Benfotiamine, Meglumine antimoniate and all biologics), the price is the documented supplier quote × 1.12 × 1.15, with the quote attached to each purchase order.
5. COMPLIANCE, TERMS AND CONTACT
Every shipment under this contract must meet the following conditions:
FDA importer registration, with GMP status verified for each source plant
DEA import permits and quotas for the controlled substances: diazepam, clonazepam, bromazepam, methylphenidate, remifentanil and esketamine
A certificate of analysis and USP specification testing on every lot
Separate BLA-pathway handling for the biologics
Delivery schedule, quality rejection rights, payment terms and termination, to be set with the contracting agency
Local contact: City of Avalon, City Hall and City Council, 410 Avalon Canyon Road, Avalon, California 90704, phone (310) 510-0220. Confirm this against the city’s official listing before signing.
Signed: Evan Winter, Fiveo1 Date _______________
6. GENERAL TERMS
Minimum Margin: Fifteen percent (15%) minimum Fiveo1 margin on all transactions. No sale shall proceed below the calculated contract floor price.
Cost Structure: Landed cost includes twelve percent (12%) for freight, insurance, customs clearance, and lot testing.
Controlled Substances: APIs marked with an asterisk (*) are controlled substances. Landed cost figures exclude DEA permit and quota fees, which shall be borne by the Buyer or added as a separate line item.
Supplier Quotes: All final purchase orders shall attach current written supplier quotes. Indicative prices in this schedule shall be replaced by documented quotes prior to execution.
Source Countries: All APIs shall be sourced exclusively from licensed manufacturers in Mexico, Brazil, Argentina, Colombia, and Guatemala as specified in the product schedule.
Quality: All APIs shall meet applicable USP, EP, or equivalent pharmacopeial standards and shall be accompanied by certificates of analysis and lot testing documentation.
Delivery: Delivery terms shall be specified in each purchase order. Title and risk transfer upon delivery to the designated US government receiving facility.
Governing Law: This contract shall be governed by the laws of the State of California and applicable federal procurement regulations.
7. SCIENTIFIC EXPLORATION, COMBINATION DEVELOPMENT AND TRANSPLANT TECHNOLOGY SITES (CALIFORNIA HIGH DESERT / INLAND EMPIRE)
The following locations in San Bernardino County, California, are designated for scientific exploration, combination development, and transplant-technology related activities supporting the biologics and advanced API program under this contract (including potential model-organism, regenerative, and supporting biological infrastructure work):
Apple Valley
Victorville
Big Bear Lake
Silverwood Lake
Spring Valley Lake
Mojave Narrows Regional Park
Jess Ranch Fish Hatchery (Apple Valley – on-site hatchery operations producing vaccinated rainbow trout and related species; established commercial aquaculture and biological production facility)
These sites may be used for combination development, scientific exploration, and transplant-technology support activities consistent with applicable federal, state, and local regulations.
8. SOURCE-SIDE LOCATION AND DEVICE METADATA (GUATEMALA)
IP Address: 190.143.186.107 (Telecomunicaciones de Guatemala / Claro network, Guatemala)
Device: Mozilla/5.0 (Linux; Android 10; K) AppleWebKit/537.36 (KHTML…
Screen: unknown
GPS: 14.738654, -91.158361
Location: Calle 15 de Febrero (Guatemala)
9. CONTACT INFORMATION
Supplier
Fiveo1
PO Box 312786
Avalon, California 90704
Santa Catalina Island
Represented by: Evan Winter (@Evan)
City of Avalon City Council / City Hall
City Hall: 410 Avalon Canyon Road, Avalon, CA 90704
Mailing: P.O. Box 707, Avalon, CA 90704
Phone: (310) 510-0220
Email: ask@cityofavalon.gov
Website: www.cityofavalon.gov
Mayor: Ann Marshall — Phone: 310-339-2935
City Manager: David Maistros — 310-510-0220, ext. 122
City Clerk: Gabrielle Morones — 310-510-0220, ext. 119
10. EXECUTION
IN WITNESS WHEREOF, the parties have executed this Bill and Contract as of the date first written above.
SUPPLIER
Fiveo1
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Evan Winter
Authorized Representative
Date: _______________
BUYER
US Government Agency
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Authorized Contracting Officer
Date: _______________
Fiveo1 Department 69 · Pharmaceutical API Exportation Bill and Contract · Avalon, Santa Catalina Island, California · October 12, 2026 ← All Articles← Home