MFDS KOREA & WHO-GMP VALIDATED PHARMACOPOEIA

Veterinary Therapeutics & Bio-Precision Formulations

Engineered in Iksan Biovalley, South Korea. Our clinical range spans targeted biologics, veterinary anti-infectives, metabolic fortifiers, and advanced companion therapeutics compliant with global CTD dossiers.

Active Pipeline0+ FormulationsExport registered in 34 countries
Quality Purity0.00% HPLCBatch-verified COA certificates
Production LineClass 0 GMPAseptic blow-fill-seal lines
R&D ValidationZero (0) WithdrawalEco-friendly enzymatic peptides
Target Species:
Formulation Matrix:
Bio-Enroflox 10% Oral Solution
POULTRYORAL SOLUTION
COA AVAILABLE
MFDS K-VET-REG #2021-081Batch Tested 99.9%

Bio-Enroflox 10% Oral Solution

High-bioavailability fluoroquinolone antimicrobial indicated for Mycoplasmosis (CRD), Colibacillosis, and infectious coryza in broilers and pullets.

Active Agent:Enrofloxacin 100mg/mL
Pack Sizes:500 mL / 1,000 mL HDPE
AvianImmune Viral Booster & Stabilizer
POULTRYSOLUBLE POWDER
COA AVAILABLE
MFDS K-VET-REG #2023-014GMP Certified

AvianImmune Viral Booster & Stabilizer

Lyophilized viral immune stimulator with beta-glucan oligosaccharides & chlorine-neutralizing dye for uniform drinking-water vaccination campaigns.

Active Agent:β-1,3/1,6-Glucan + Astragalus
Pack Sizes:100g, 500g, 1kg Sealed Foil
Biomleex Max-Growth FCR Conditioner
POULTRYGUT CONDITIONER
COA AVAILABLE
MFDS K-VET-REG #2022-119Zero Withdrawal

Biomleex Max-Growth FCR Conditioner

Proprietary synbiotic blend containing Korean multi-strain Bacillus subtilis, amino chelates, and phytase for peak Feed Conversion Ratio and eggshell density.

Active Agent:B. subtilis + B. licheniformis
Pack Sizes:1kg, 5kg, 25kg Kraft Drum
AvianVite Ultra Pigeon & Exotic Vitality
AVIAN / EXOTICSORAL DROPS
COA AVAILABLE
MFDS K-VET-REG #2024-002Fast Bio-Uptake

AvianVite Ultra Pigeon & Exotic Vitality

High-concentration fat-soluble Vitamin ADEK3 + Carnitine formulated for racing pigeons, falconry raptors, and psittacine feather recovery.

Active Agent:A, D3, E, K3 + L-Carnitine
Pack Sizes:100 mL, 250 mL Dropper Bottle
CalciMag-P Super Liquid Infusion
LIVESTOCKORAL DRENCH
COA AVAILABLE
MFDS K-VET-REG #2020-049Rapid Serum Ca

CalciMag-P Super Liquid Infusion

High-potency calcium, magnesium & phosphorus metabolic oral gel drench engineered to prevent subclinical hypocalcemia (milk fever) in dairy cows and small ruminants.

Active Agent:Ionic Ca (65g) + Mg + P + Propylene
Pack Sizes:500 mL Drench Cartridge / 5L Jug
IverBiomleex Injectable 1% Parasiticide
LIVESTOCKINJECTABLE SOLUTION
COA AVAILABLE
MFDS K-VET-REG #2019-331Sub-Q Depot

IverBiomleex Injectable 1% Parasiticide

Prolonged-release endectocide solution targeting gastrointestinal roundworms, lungworms, grubs, sucking lice, and mange mites in bovine and swine herds.

Active Agent:Ivermectin 10mg/mL (Sterile)
Pack Sizes:50 mL, 100 mL, 500 mL Type I Glass
MastiCure Gold Intramammary Infusion
LIVESTOCKINTRAMAMMARY
COA AVAILABLE
MFDS K-VET-REG #2021-140Lactating Cow Safe

MastiCure Gold Intramammary Infusion

Synergistic Cefalexin and Kanamycin intramammary therapeutic designed for rapid clearance of clinical mastitis caused by Gram-positive and Gram-negative udder pathogens.

Active Agent:Cefalexin 200mg + Kanamycin 100k IU
Pack Sizes:10g Pre-filled Syringes (24/box)
ReproSafe Hormonal & Recovery Solution
LIVESTOCKINJECTABLE SOLUTION
COA AVAILABLE
MFDS K-VET-REG #2023-401Bovine & Porcine

ReproSafe Hormonal & Recovery Solution

Synthetic prostaglandin F2-alpha analogue (Cloprostenol sodium) for precision estrus synchronization, luteolysis, and postpartum uterine cleansing.

Active Agent:d-Cloprostenol Sodium 0.075mg/mL
Pack Sizes:20 mL, 50 mL Rubber-stoppered Vials
DermBiomleex Medicated Shampoo
CANINE & FELINEMEDICATED SHAMPOO
COA AVAILABLE
MFDS K-VET-REG #2022-772Soap-Free Base

DermBiomleex Medicated Shampoo

Clinical therapeutic formulation combining Chlorhexidine Gluconate and Ketoconazole for resistant Malassezia dermatitis and superficial pyoderma.

Active Agent:Chlorhexidine 2% + Ketoconazole 1%
Pack Sizes:250 mL, 500 mL, 3.8 L Clinic Refill
ArthriFlex Plus Cartilage Soft Chews
CANINE & FELINESOFT CHEWS
COA AVAILABLE
MFDS K-VET-REG #2023-88994% Palatability

ArthriFlex Plus Cartilage Soft Chews

High-potency chondroprotective formulation enriched with low-molecular Korean marine collagen peptides, Glucosamine HCl, Chondroitin, and Antarctic Krill Omega-3.

Active Agent:Glucosamine 600mg + Marine Collagen
Pack Sizes:60 Chews / 120 Chews Tub
TotalWormer Pro Broad-Spectrum Tablets
CANINE & FELINEORAL TABLETS
COA AVAILABLE
MFDS K-VET-REG #2020-515Broad Coverage

TotalWormer Pro Broad-Spectrum Tablets

Triple-action anthelmintic eliminating tapeworms, hookworms, roundworms, and whipworms in dogs and cats with single-dose efficacy.

Active Agent:Praziquantel + Pyrantel + Febantel
Pack Sizes:10 Tablets / Blister (Box of 50)
HepatoBiomleex Liver & Renal Formula
CANINE & FELINEORAL SUSPENSION
COA AVAILABLE
MFDS K-VET-REG #2024-118Cell Longevity

HepatoBiomleex Liver & Renal Formula

Micronized Silybin-phospholipid complex with SAMe and Korean Red Ginseng extract, clinically shown to reduce elevated ALT/AST and support senior pet hepatic perfusion.

Active Agent:Silybin Phytosome + SAMe + Taurine
Pack Sizes:60 mL Calibrated Syringe Dropper
KOREAN MFDS GMP AUDITED DOSSIERS

Institutional Export Packaging & Pharmacopoeia Documentation

Every BIOBIOMLEEX KR product is delivered with complete Common Technical Dossiers (CTD), accelerated stability studies (ICH Q1A), and Certificate of Free Sale (CFS) authenticated by the Korean Ministry of Food and Drug Safety.

Full Dossier Support

Modules 1 to 5 available for fast foreign country registration.

In-House HPLC Labs

Chromatography fingerprinting verifying potency stability.

2025 OFFICIAL MONOGRAPH

2025 Product Compendium

148 Pages

Complete scientific monograph including full active ingredient matrices, therapeutic indication charts, withdrawal periods, and packaging logistics.

▸File Format:Interactive PDF
▸Language Editions:English · Korean · Spanish
▸Release Date:January 2025 Revision

Table of Formulations & Regulatory Monograph

12 Commercial Formulations
Reg #Product NameActive AgentSpeciesQuality Standard
MFDS K-VET-REG #2021-081Bio-Enroflox 10% Oral SolutionEnrofloxacin 100mg/mLPOULTRYBatch Tested 99.9%
MFDS K-VET-REG #2023-014AvianImmune Viral Booster & Stabilizerβ-1,3/1,6-Glucan + AstragalusPOULTRYGMP Certified
MFDS K-VET-REG #2022-119Biomleex Max-Growth FCR ConditionerB. subtilis + B. licheniformisPOULTRYZero Withdrawal
MFDS K-VET-REG #2024-002AvianVite Ultra Pigeon & Exotic VitalityA, D3, E, K3 + L-CarnitineAVIAN / EXOTICSFast Bio-Uptake
MFDS K-VET-REG #2020-049CalciMag-P Super Liquid InfusionIonic Ca (65g) + Mg + P + PropyleneLIVESTOCKRapid Serum Ca
MFDS K-VET-REG #2019-331IverBiomleex Injectable 1% ParasiticideIvermectin 10mg/mL (Sterile)LIVESTOCKSub-Q Depot
MFDS K-VET-REG #2021-140MastiCure Gold Intramammary InfusionCefalexin 200mg + Kanamycin 100k IULIVESTOCKLactating Cow Safe
MFDS K-VET-REG #2023-401ReproSafe Hormonal & Recovery Solutiond-Cloprostenol Sodium 0.075mg/mLLIVESTOCKBovine & Porcine
MFDS K-VET-REG #2022-772DermBiomleex Medicated ShampooChlorhexidine 2% + Ketoconazole 1%CANINE & FELINESoap-Free Base
MFDS K-VET-REG #2023-889ArthriFlex Plus Cartilage Soft ChewsGlucosamine 600mg + Marine CollagenCANINE & FELINE94% Palatability
MFDS K-VET-REG #2020-515TotalWormer Pro Broad-Spectrum TabletsPraziquantel + Pyrantel + FebantelCANINE & FELINEBroad Coverage
MFDS K-VET-REG #2024-118HepatoBiomleex Liver & Renal FormulaSilybin Phytosome + SAMe + TaurineCANINE & FELINECell Longevity

Detailed Formulation Specifications & Clinical Monographs

CTD Modules 1–5 Compliant
MFDS K-VET-REG #2021-081 • ORAL SOLUTION

Bio-Enroflox 10% Oral Solution

POULTRY

Active Agent: Enrofloxacin 100 mg / mL (High Bioavailability Formulation)

Indication: Indicated for infectious respiratory & enteric diseases in poultry caused by Mycoplasma gallisepticum, Mycoplasma synoviae, E. coli, Pasteurella multocida, and Salmonella spp.

Dosage: Oral via drinking water: 10 mg enrofloxacin / kg bodyweight daily for 3–5 consecutive days (approx. 50 mL per 100 Litres of drinking water).
Withdrawal: Meat & Offal: Broilers 8 days. Not permitted for use in birds producing eggs for human consumption.
MFDS K-VET-REG #2023-014 • SOLUBLE POWDER

AvianImmune Viral Booster & Stabilizer

POULTRY

Active Agent: Lyophilized Astragalus Polysaccharides, Beta-1,3/1,6-Glucan, Sodium Thiosulfate dye

Indication: Immune adjuvancy for Newcastle Disease, Infectious Bronchitis (IB), and Gumboro (IBD) vaccination. Neutralizes chlorine in tap water and stains tongue blue for intake monitoring.

Dosage: Dissolve 100 g powder per 200–400 Litres of drinking water 15 minutes prior to live vaccine administration. Maintain during high heat stress periods.
Withdrawal: Zero (0) Days. Chemical free biological nutritional booster.
MFDS K-VET-REG #2022-119 • GUT CONDITIONER

Biomleex Max-Growth FCR Conditioner

POULTRY

Active Agent: Bacillus subtilis BIO-K7 (1.2 x 10^10 CFU/g), Bacillus licheniformis, Phytase, Protease enzymes

Indication: Stabilizes poultry intestinal microflora, lowers intestinal pH, accelerates feed conversion ratio (FCR), and boosts shell calcium binding capacity in commercial layers.

Dosage: Mix 500 g to 1 kg per metric ton of complete poultry feed continuously throughout brooding, rearing, and egg laying phases.
Withdrawal: Zero (0) Days. Probiotic natural biological feed fortifier.
MFDS K-VET-REG #2024-002 • ORAL DROPS

AvianVite Ultra Pigeon & Exotic Vitality

AVIAN / EXOTICS

Active Agent: Vitamin A 2,500,000 IU, D3 500,000 IU, E 3,000 mg, K3 1,200 mg, L-Carnitine 10,000 mg/L

Indication: Optimized vitality, feather molt sheen, muscle recovery after long-distance flights, and fertility boosting for breeding pairs of racing pigeons, falcons, and psittacines.

Dosage: Racing Pigeons: 1 mL per 1 Litre of drinking water for 2 consecutive days per week. Exotics/Caged Birds: 2 drops per 100 mL water dispenser.
Withdrawal: Zero (0) Days. Clean bio-vitamin supplement.
MFDS K-VET-REG #2020-049 • ORAL DRENCH

CalciMag-P Super Liquid Infusion

LIVESTOCK

Active Agent: Available Ionic Calcium (65 g), Magnesium (15 g), Phosphorus (10 g) + Propylene Glycol per 500 mL

Indication: Rapid prevention and adjunctive therapy for clinical and subclinical hypocalcemia (parturient paresis/milk fever) and ketosis in dairy cows, sheep, and dairy goats.

Dosage: Dairy Cattle: Administer 1 container (500 mL) orally 12–24 hours prior to calving, followed by a second bottle immediately after calving. Repeat in 12 hours if needed.
Withdrawal: Meat: 0 Days. Milk: 0 Hours.
MFDS K-VET-REG #2019-331 • INJECTABLE SOLUTION

IverBiomleex Injectable 1% Parasiticide

LIVESTOCK

Active Agent: Sterile Ivermectin 10 mg / mL in low-viscosity non-aqueous vehicle

Indication: Broad spectrum treatment and control of gastrointestinal nematodes, lungworms, eyeworms, warble flies, psoroptic and sarcoptic mange, and sucking lice in cattle, swine, and sheep.

Dosage: Cattle & Sheep: 1 mL per 50 kg body weight administered strictly via subcutaneous injection in front of or behind the shoulder. Swine: 1 mL per 33 kg body weight.
Withdrawal: Cattle Meat: 35 days. Swine Meat: 18 days. Do not administer to lactating dairy animals producing milk for consumption.
MFDS K-VET-REG #2021-140 • INTRAMAMMARY

MastiCure Gold Intramammary Infusion

LIVESTOCK

Active Agent: Cefalexin Monohydrate 200 mg + Kanamycin Monosulphate 100,000 IU per 10 g syringe

Indication: Clinical mastitis in lactating dairy cows caused by Staphylococcus aureus, Streptococcus uberis, Streptococcus dysgalactiae, and Escherichia coli.

Dosage: Infuse contents of one syringe into each infected quarter immediately after milking. Repeat after 24 hours. Up to 4 consecutive infusions.
Withdrawal: Meat & Offal: 7 days. Milk: 84 hours (7 milkings) post last treatment.
MFDS K-VET-REG #2023-401 • INJECTABLE SOLUTION

ReproSafe Hormonal & Recovery Solution

LIVESTOCK

Active Agent: d-Cloprostenol Sodium 0.075 mg / mL (Biologically Active D-Enantiomer)

Indication: Estrus synchronization, silent heat, chronic endometritis, pyometra, luteal cysts, and termination of unwanted gestation in cattle and swine.

Dosage: Intramuscular injection: Cattle 2.0 mL (0.150 mg d-cloprostenol); Swine 1.0 mL (0.075 mg d-cloprostenol) for farrowing induction within 3 days of expected term.
Withdrawal: Cattle Meat: 24 hours. Milk: Zero (0) hours. Swine Meat: 24 hours.
MFDS K-VET-REG #2022-772 • MEDICATED SHAMPOO

DermBiomleex Medicated Shampoo

CANINE & FELINE

Active Agent: Chlorhexidine Gluconate 2.0% w/v, Ketoconazole 1.0% w/v with Ceramide micro-lipid repair

Indication: Topical antibacterial and antifungal management of infectious dermatitis, recurrent Malassezia pachydermatis overgrowth, and superficial pyoderma in canines and felines.

Dosage: Wet coat thoroughly with warm water, apply shampoo and lather generously. Allow contact with skin for 10 full minutes before thoroughly rinsing. Repeat 2-3 times weekly.
Withdrawal: Topical veterinary application. Not applicable for food animals.
MFDS K-VET-REG #2023-889 • SOFT CHEWS

ArthriFlex Plus Cartilage Soft Chews

CANINE & FELINE

Active Agent: Glucosamine HCl 600 mg, Chondroitin Sulfate 300 mg, Marine Collagen 250 mg, Krill Omega-3 150 mg

Indication: Management of osteoarthritis, hip dysplasia, joint stiffness, and age-related cartilage degradation in active, working, and senior dogs.

Dosage: Under 10 kg: 1 chew daily. 10–25 kg: 2 chews daily. 25–45 kg: 3 chews daily. Over 45 kg: 4 chews daily. Can be doubled during initial 3-week loading phase.
Withdrawal: Companion animal nutritional therapeutic. Not for food animal consumption.
MFDS K-VET-REG #2020-515 • ORAL TABLETS

TotalWormer Pro Broad-Spectrum Tablets

CANINE & FELINE

Active Agent: Praziquantel 50 mg, Pyrantel Embonate 144 mg, Febantel 150 mg

Indication: Complete deworming eliminating Ascarids (Toxocara canis, Toxascaris leonina), Hookworms (Ancylostoma caninum), Whipworms (Trichuris vulpis), and Tapeworms (Dipylidium caninum).

Dosage: 1 tablet per 10 kg body weight administered orally directly or concealed in meat. No fasting required prior to treatment. Routine administration every 3 months.
Withdrawal: Companion animal prescription. Not for food-producing animals.
MFDS K-VET-REG #2024-118 • ORAL SUSPENSION

HepatoBiomleex Liver & Renal Formula

CANINE & FELINE

Active Agent: Silybin Phospholipid 100 mg, S-Adenosylmethionine (SAMe) 90 mg, Taurine, Korean Panax Ginseng

Indication: Hepatic support during toxic insult, hepatitis, liver fibrosis, bile stasis, and age-related renal insufficiency in canines and felines.

Dosage: Oral suspension: 1 mL per 5 kg body weight once daily, preferably on an empty stomach or with a light meal for optimized SAMe absorption.
Withdrawal: Companion animal therapeutic supplement. Not for food animal consumption.

International Regulatory Dossier Index (CTD Modules 1 to 5)

Module 1: AdministrativeCertificate of Free Sale (CFS), GMP Audit, Packaging Labels
Module 2: Quality SummariesOverall Quality Summary (QOS), Nonclinical & Clinical Overview
Module 3: Quality ControlAPI Synthesis, HPLC Assay Validation, 36-Month Stability Data

ICH Q1A Stability & Bioavailability Certified

Real-time 36-month shelf stability data validated under tropical Zone IVB conditions (30°C / 75% RH).

Korean Ministry of Food & Drug Safety (MFDS)

Certificate of Free Sale (CFS) authenticated for direct foreign country regulatory submission.

BIOBIOMLEEX KR Co., Ltd. • Iksan Biovalley R&D Complex, Jeollabuk-do, South Korea • Document ID: PHARM-2025-KR • Page 1 of 3