| HS Code | 232782 |
| Product Name | Fenni Veterinary Grade API |
| Product Type | Active Pharmaceutical Ingredient |
| Grade | Veterinary Grade |
| Suitable Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Intended Species | Veterinary animals |
| Physical Form | Crystalline or amorphous powder |
| Appearance Color | White or off-white |
| Solubility | Suitable for incorporation into solid and liquid veterinary formulations |
| Assay Purity | Meets or exceeds pharmacopoeial specification |
| Loss On Drying | Conforms to pharmacopoeial limits |
| Residue On Ignition | Conforms to pharmacopoeial limits |
| Heavy Metals Content | Conforms to pharmacopoeial limits |
| Storage Conditions | Store in a tightly sealed, light-resistant container in a cool, dry place |
| Shelf Life | 24-36 months depending on retest date |
| Packaging Options | Bulk drums with airtight liners |
| Regulatory Compliance | Manufactured under GMP with veterinary pharmacopoeial compliance |
As an accredited Fenni Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Fenni veterinary-grade API is packaged in 25 kg sealed drums with tamper-proof inner lining, ensuring stability and safe transport. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Fenni Veterinary Grade API, safely packed in sealed drums, palletized and secured. |
| Shipping | Fenni Veterinary Grade API is shipped in sealed, inert containers with tamper-evident packaging. Transport is via temperature-controlled, moisture-protected logistics, screened from sunlight. Documentation includes Material Safety Data Sheet and certificate of analysis. Handling requires protective equipment, and shipments comply with international regulations for pharmaceutical ingredients, ensuring stability and safety throughout transit. |
| Storage | Store Fenni Veterinary Grade API in tightly sealed, original containers, away from moisture, direct sunlight, and heat. Keep in a cool, dry, well-ventilated area, ideally below 25°C. Avoid contact with incompatible substances, food, and feed. Ensure proper labeling, restricted access, and adherence to local regulations. Use appropriate PPE when handling. |
| Shelf Life | Shelf life is typically 2–3 years when stored in original, sealed containers under cool, dry, and dark conditions. |
Fenni fenbendazole veterinary-grade API (CAS 43210-67-9) is introduced into swine medicated feed premix manufacture as a micronized active with a target particle-size distribution of D90 ≤ 20 µm and D50 ≤ 8 µm. The chosen particle-size window limits segregation during pneumatic conveying and transfer auger discharge into mass-flow batch mixers. Premix use in the United States falls under 21 CFR 558.258 as a Type A medicated article, while European food-safety withdrawal requirements are anchored to the MRL marker residue definition in EU Commission Regulation 37/2010, where the marker residue is the sum of fenbendazole, fenbendazole sulfoxide, and fenbendazole sulfone. The addition ratio is calculated from a dosage of 3 mg/kg body weight per day for 3 consecutive days; at a feed intake of 5 % body weight per day, complete feed inclusion is approximately 60 ppm active, requiring a 4 % w/w premix to be included at 1.5 kg per tonne of finished feed. Manufacture uses a ribbon blender with ribbon-to-shell clearance 3–5 mm; the API is first geometrically diluted with lactose monohydrate or soybean meal through a 600 µm mesh sifter to reduce agglomerates, then blended at 15–20 rpm for 15–20 min until active-content relative standard deviation across 10 sampling points remains at or below 5 %. Batch-to-batch variance on production lines is most commonly driven by post-milling particle-size drift; an increase in D90 above 30 µm correlates with segregation and final feed assay failure at the 0.9× label-claim limit. Terminal products include 4 % w/w and 20 % w/w fenbendazole premixes packed in 25 kg paper-polyethylene valve bags for feed mill incorporation or on-farm top-dressing.
| Premix strength | Complete feed target | Premix inclusion | Use point |
|---|---|---|---|
| 4% w/w | 60 ppm | 1.5 kg/tonne | Feed mill bulk mixing |
| 20% w/w | 60 ppm | 0.3 kg/tonne | On-farm top dressing with pre-blend |
Oral suspension drench manufacture for cattle and sheep uses Fenni fenbendazole API at a final concentration of 100 mg/mL (10% w/v), with a dose of 5 mg/kg body weight administered by oral drench. The compliance framework includes VICH GL18 for bioequivalence of veterinary medicinal products and EU Commission Regulation 37/2010, under which the MRL marker residue is defined as the sum of fenbendazole, fenbendazole sulfoxide, and fenbendazole sulfone; liver MRL is 500 µg/kg, while muscle and kidney MRLs are 50 µg/kg for bovine and ovine species. The addition ratio is 100 mg active per 1 mL suspension, supported by a suspending system comprising xanthan gum at 0.2–0.3 % w/v and microcrystalline cellulose/carboxymethylcellulose sodium at 1.0–1.5 % w/v, with polysorbate 80 at 0.2 % w/v as wetting agent. The dispersion sequence begins with high-shear rotor-stator mixing of the API in an aqueous wetting-agent premix at 3,000–3,500 rpm for 15 min, followed by high-pressure homogenization at 800–1,000 bar. Final viscosity at 20 °C is controlled to 800–1,500 mPa·s using rotational viscometer spindle 2 at 60 rpm. Sedimentation volume after 24 hours at 25 °C remains above 0.8 mL/mL, and re-dispersibility requires fewer than 5 inversions to return to uniform suspension. Terminal products are 1 L and 2.5 L high-density polyethylene drench packs fitted with calibrated oral dosing guns; in-use stability after first opening is controlled to 6 months when stored below 25 °C.
Direct encapsulation of Fenni fenbendazole veterinary-grade API into 250 mg hard gelatin capsules for canine therapy requires a pre-blend containing 42–45 % w/w active, 38–42 % w/w microcrystalline cellulose PH-102, 8–10 % w/w croscarmellose sodium, 2–3 % w/w povidone K30, and 0.5–1.0 % w/w magnesium stearate. The compliance basis is the USP Fenbendazole monograph and Ph. Eur. 2.9.40 uniformity of dosage units; finished hard capsules are tested for dissolution per Ph. Eur. 2.9.3 using 0.1 M hydrochloric acid with 1 % sodium dodecyl sulfate as medium at a paddle speed of 75 rpm. The production sequence uses a V-blender at 60–70 % fill volume for 20 min, followed by encapsulation on a dosator-type capsule filler operating at 30,000–60,000 capsules/h. In-process fill-weight control is maintained with a sorter and checkweigher accepting a range of ±3 % of target fill weight. Because the API is poorly water-soluble, micronization to D90 ≤ 20 µm is sufficient for blend uniformity, but over-milling below D50 5 µm increases electrostatic adhesion to the dosator tip and requires relative humidity control below 45 % RH. Terminal products are 250 mg capsules blister-packed in aluminum-PVC/PE/PVDC laminate for small-animal dispensing.
Tablet cores containing 250 mg and 500 mg fenbendazole per unit are manufactured by high-shear wet granulation rather than direct compression because the API’s poor aqueous solubility and low bulk density create segregation risk in direct-compression blends. The core formula uses 40–55 % w/w fenbendazole, 20–30 % w/w microcrystalline cellulose, 10–20 % w/w lactose monohydrate 200 M, 3–5 % w/w povidone K30 as binder, 4–6 % w/w crospovidone as disintegrant, and 0.5–1.0 % w/w magnesium stearate as lubricant. Compliance is maintained under Ph. Eur. 2.9.5 uniformity of mass of single-dose preparations, Ph. Eur. 2.9.7 disintegration, Ph. Eur. 2.9.3 dissolution, Ph. Eur. 2.9.40 uniformity of dosage units, and 21 CFR 211 cGMP for finished pharmaceuticals. A 100 kg batch is granulated in a high-shear mixer-granulator at impeller speed 250–350 rpm and chopper speed 1,500–2,500 rpm; purified water is added through a nozzle at 6–10 kg/min to a granulation endpoint of 8–12 % w/w moisture. The wet mass is discharged through a 4.0 mm screen and dried in a fluid-bed dryer at inlet temperature 55–65 °C to final loss on drying 1.5–2.5 % w/w. The dried granule is milled through a 1.0 mm screen and lubricated in a bin blender at 10–15 rpm for 5 min. Tablets are compressed on a 12-station rotary press with compression force 12–20 kN to hardness 80–120 N and friability ≤0.8 %; disintegration time is ≤15 min in water at 37 °C. Aqueous film coating to 2–3 % weight gain is applied in a perforated pan coater with inlet air temperature 55–65 °C and pan speed 6–10 rpm. Terminal products are 250 mg and 500 mg oval film-coated tablets in 10-count or 20-count blister packs.
A 10 % w/w equine oral paste formulation uses Fenni fenbendazole API at a dose of 5 mg/kg body weight for routine strongyle control. The compliance basis is VICH GL18 for bioequivalence and EU Commission Regulation 37/2010 for MRL marker residue in equine tissues. The API is dispersed at 10 g per 100 g paste into a non-aqueous carrier consisting of propylene glycol 20–25 % w/w, glycerin 20–25 % w/w, colloidal silicon dioxide 2–3 % w/w, and hydroxyethyl cellulose 1–1.5 % w/w. Micronized API with D90 ≤ 15 µm is first wetted with propylene glycol in a planetary mixer, after which silica and cellulosic thickeners are added under vacuum at −0.08 MPa and 25–30 rpm for 30–40 min to avoid air entrapment. The finished paste is tested for extrudability at 20 °C through a 2 mm orifice under 10 N force, with a target extrusion rate of 1.5–2.5 g/s. Terminal products are 25 g multi-dose oral syringes calibrated to deliver 5 g per 100 kg body weight.
Fenni fenbendazole veterinary-grade API in injectable suspension form is handled as a low-solubility sterile powder with bulk density 0.30–0.45 g/mL; aqueous solubility below 0.01 mg/mL limits the formulation to a suspension rather than a solution. The addition ratio is 100 mg/mL active (10% w/v) in an aqueous vehicle containing sodium carboxymethylcellulose 0.25–0.5 % w/v, polysorbate 80 at 0.1–0.3 % w/v, and preservatives methylparaben 0.15 % w/v and propylparaben 0.02 % w/v. Compliance is maintained under 21 CFR 211, EU GMP Annex 1 for sterile medicinal products, and Ph. Eur. 2.6.1 sterility. The vehicle is steam-sterilized at 121 °C for 15 min, while the suspended API is sterilized by dry-heat or gamma irradiation; aseptic compounding takes place in a Class B environment with a Class A filling line. The suspension is filled into 100 mL Type I glass vials through a 10 mL positive-displacement pump with nitrogen flushing to limit oxygen exposure. Published data for this specific configuration is limited; terminal steam sterilization of the suspension may be used only after forced degradation studies confirm assay retention above 95 % after 121 °C/15 min, otherwise aseptic filling of pre-sterilized API is required. In-use stability after first needle puncture is limited by preservative efficacy testing per Ph. Eur. 5.1.3. Terminal products are 100 mL multidose vials with bromobutyl rubber stoppers and aluminum caps.
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Product model codes for Fenni Veterinary Grade API are FEN-VAPI-2207 for oral solid and premix applications and FEN-VAPI-2207-S for injectable and solution applications; these codes refer to the same chemical entity but are differentiated by final crystallization, sieving, drying, and packaging conditions. The designation covers one chemically defined active pharmaceutical ingredient, not a formulated blend. Separate particle-size, microbial, and physical-characterization targets are applied to tablets, capsules, powders, granules, premixes, injectable solutions, and oral solutions. Released material is manufactured under ICH Q7 and EU GMP Part II and is supported by an active substance master file, batch manufacturing record, and certificate of analysis. Residual solvent data are generated by headspace gas chromatography according to VICH GL18, elemental impurities by inductively coupled plasma mass spectrometry according to USP <232>/<233>, and bacterial endotoxin by the photometric limulus amebocyte lysate method in Ph. Eur. 2.6.14. The material is labeled for veterinary use only under Regulation (EU) 2019/6 and is not a sterile finished dosage form.
Table 1 summarizes route-specific release controls. Values are lot-specific and are confirmed on each certificate of analysis; they are not finished-product specifications.
| Property | Method | Acceptance criterion |
|---|---|---|
| Identification | IR spectrophotometry per Ph. Eur. 2.2.24 | Concordant with reference spectrum |
| Assay | HPLC per Ph. Eur. 2.2.29 | 98.0–102.0% w/w on the anhydrous, solvent-free basis for oral routes; 99.0–101.0% w/w for injectable-grade lots |
| Total impurities | HPLC normalized area | ≤1.0% w/w; unspecified impurity ≤0.10% w/w |
| Residual solvents | Headspace GC per VICH GL18 | Class 1 solvents not detected; Class 2 solvents within permitted daily exposure |
| Elemental impurities | ICP-MS per USP <232>/<233> | Route-based limits; oral and injectable options are batch-certified |
| Loss on drying | Ph. Eur. 2.2.32 | ≤0.5% w/w for oral grade; ≤0.2% w/w for injectable grade |
| Particle size distribution | Laser diffraction per ISO 13320 | Direct-compression grade d90 75–150 µm; premix grade d90 ≤250 µm |
| Polymorphic form | XRPD per Ph. Eur. 2.9.33 | Crystalline form A only; amorphous content ≤2% w/w |
| Bulk density and tapped density | Ph. Eur. 2.9.34 | Bulk 0.35–0.55 g/mL; tapped 0.55–0.75 g/mL |
| Microbial quality | Ph. Eur. 2.6.12/2.6.13 | Oral grade TAMC ≤100 CFU/g; TYMC ≤20 CFU/g |
| Bacterial endotoxins | Ph. Eur. 2.6.14 | Injectable grade ≤0.25 EU/mg unless a lower route-specific limit is calculated from maximum daily dose |
The product line includes three packaging configurations for non-sterile API. Standard 25 kg lots are supplied in double low-density polyethylene liners inside an aluminium foil laminate bag, with desiccant where loss on drying is specified below 0.5% w/w. Reduced-bioburden injectable-grade material is packed in 5 kg sterile-transfer bags or 10 L gamma-irradiated containers with an external lip that permits connection to an isolator operated at ISO 14644-1 class 7 or better. Each container is labeled with batch number, production date, retest date, storage condition, and veterinary-only statement. The documentation package includes a certificate of analysis using the same monograph acceptance criteria as the active substance master file, a statement of GMP compliance, and a transport-stability record. For premix and granule applications, a 20 kg fiber drum with antistatic liner is substituted to reduce dust generation during transfer. A residue-free pressure-sensitive label is used because solvent migration into the API crystal lattice is possible if the container is exposed to temperatures above 40 °C during bulk storage.
Tablet and capsule grades are not identical to premix or injectable grades. The oral solid material is milled under nitrogen and sieved so that particle-size distribution by laser diffraction conforms to a typical d90 of 75–150 µm and d50 of 40–70 µm; this range is confirmed according to ISO 13320 and is selected to limit segregation in direct-compression blends containing microcrystalline cellulose and lactose monohydrate. On a rotary tablet press operating at 60–80 rpm, weight-variation drift beyond ±3% is observed when the fraction retained on a 150 µm sieve exceeds 5% w/w. The same grade is suitable for low-shear tumble blending, but high-shear planetary mixing at 150 rpm for longer than 10 minutes can increase average blend temperature by 8–12 °C; this condition is not typically used because the amorphous content may rise above 2% w/w as determined by X-ray powder diffraction per Ph. Eur. 2.9.33. For capsules, the powder is conditioned to 30–45% relative humidity before encapsulation to reduce static adhesion to gelatin and hypromellose capsule shells.
Injectable solution preparation requires the FEN-VAPI-2207-S grade because the standard oral grade does not provide the same bioburden and endotoxin envelope. The injectable grade is crystallized from a water-for-injection-compatible solvent system and dried at low terminal temperature so that bacterial endotoxin is held below 0.25 EU/mg when the calculated limit from the maximum daily dose is not stricter. In downstream compounding, a 10–20% w/v stock solution is prepared in water for injection adjusted to pH 5.5–6.5 with hydrochloric acid or sodium hydroxide; the solution is passed through a 0.22 µm PVDF membrane cartridge that has been pre-flushed with water for injection to avoid leachables. Membrane fouling at 0.5 bar differential pressure is the limiting operational boundary; above 0.5 bar, the filter is replaced because flux decline is associated with gel-like associated species rather than raw-material insolubility. Aseptic filling of the filtered solution into glass vials is performed under ISO 14644-1 class 5 conditions. The API is not terminally sterilized as supplied and must not be treated as a sterile powder.
Premix and granule production uses a co-milled or granulated grade to prevent segregation and dusting. The base API is blended with a carrier such as calcium carbonate, lactose, or wheat middlings in a ribbon mixer at 15–25 rpm for 10–20 minutes. Blend uniformity is determined by taking 10 unit-dose samples and analyzing the active substance by stability-indicating HPLC; the acceptance criterion is relative standard deviation ≤5.0% and mean assay within 90.0–110.0% of label claim. Segregation is more pronounced when the particle-size ratio between active and carrier exceeds 1:3; therefore the premix grade is milled to a d90 below 250 µm and a d10 above 20 µm. In field-scale horizontal paddle mixers with working volumes of 1,000–3,000 L, batch charging order influences dust loss and recoverable assay; the active is added after 70% of the carrier has been loaded, and a minimum of 12 minutes of mixing after the final component addition is held. For granulated premixes, water or a binder solution is sprayed at 2–5% w/w during high-shear mixing; granule growth is halted when the wet mass passes a 2.0 mm screen and the granules are tray-dried to a final loss on drying below 5.0% w/w. Drying air above 60 °C is avoided because surface discoloration increases without improving residual moisture. For medicated feed applications, these data are intended to support downstream compliance with 21 CFR Part 225 and 21 CFR Part 558, but the API itself is not a finished medicated feed.
Powder and solution grades are not interchangeable. Water-soluble powder for oral solution is produced as a spray-dried or freeze-dried material with a dissolution performance criterion of complete dissolution in water at 20 ± 2 °C within 5 minutes under 200 rpm stirring as measured using a mini-volume paddle method based on USP <711>; failure is defined by retention on a 45 µm sieve after the dissolution interval. The same grade is tested for clarity and pH change when reconstituted at 10 mg/mL, but the finished product vendor is responsible for taste-masking and preservative-loading studies. For non-aqueous oral solutions, the API is dissolved in a solvent system containing propylene glycol or glycerol formal; residual water is controlled to ≤0.5% w/w to avoid esterification and crystal growth during storage. The granulated grade is intended for drinkers, drenching, or medicated feed; it is not suitable for injectable formulation because the granulation binder leaves water-insoluble residue. Each of these route-specific distinctions is documented on the certificate of analysis; the user must not substitute grades without a documented risk assessment because the differences are not limited to particle size but include residual solvent selection, bioburden, and stabilizing excipients.
The phrase “veterinary grade API” is not equivalent to technical-grade fine chemical, compounded pharmaceutical ingredient, or reference standard. Technical-grade material supplied for feed or industrial conversion may be produced under continuous chemical synthesis without batch-to-batch impurity control and commonly contains elemental impurities or residual solvents above the acceptance limits in VICH GL18 and USP <232>/<233>. Fenni Veterinary Grade API is released under ICH Q7 and EU GMP Part II with a defined impurity profile and stability data. A compounding pharmacy API may be sourced from a legitimate manufacturer but may lack the same route-specific particle engineering, endotoxin control, or supply-chain documentation. A chemical reference standard is intended for method validation, system suitability, or identification; it is not manufactured to be formulated into a commercial dose. The Fenni product differs from these categories in four operational parameters: route-specific particle size control, polymorph consistency against a designated crystalline form, bacterial endotoxin control for injectable grades, and complete GMP documentation including annual product quality review. For an API that is to be used in multiple formulations, the single multi-route monograph approach reduces specification fragmentation; however, it does not remove the need for finished product stability testing under the final formulation and packaging.
| Attribute | Fenni veterinary grade API | Technical or feed grade | Reference standard or laboratory chemical |
|---|---|---|---|
| Manufacturing framework | ICH Q7, EU GMP Part II, active substance master file | No GMP commitment; can be reprocessed without batch linkage | ISO 17025 reference material only |
| Route suitability | Tablets, injections, capsules, powders, granules, premix, solutions | Not intended for parenteral or oral pharmaceutical formulations | Method qualification; not for patient use |
| Impurity and solvent envelope | VICH GL18 residual solvent limits; USP <232>/<233> elemental impurity route-based limits | May contain Class 1 solvents or undefined heavy-metal burden | Declared purity only; no toxicological evaluation for dosage form use |
| Physical characterization | XRPD polymorphic form per Ph. Eur. 2.9.33; particle size per ISO 13320; bulk and tapped density per Ph. Eur. 2.9.34 | Sieve distribution only, if available | Spectroscopic identity and chromatographic purity only |
| Microbial and endotoxin status | TAMC/TYMC per Ph. Eur. 2.6.12/2.6.13; endotoxin per Ph. Eur. 2.6.14 for injectable grade | Generally uncontrolled unless explicitly requested | Not validated for use in a sterile manufacturing train |
| Documentation | Certificate of analysis, stability summary, annual product quality review, GMP statement | Limited certificate of analysis; no GMP statement; no stability commitment | Reference certificate with purity and storage instructions |
Operational boundaries are defined by route. The oral grade is not suitable for injectable use because the bioburden and endotoxin results are not guaranteed for parenteral administration. The injectable grade is not optimized for direct compression because its particle-size range and bulk and tapped density produce poor flow and low compactability. The premix grade should not be used in sterile filtration without additional purification. The material is incompatible with strong oxidizing agents, strong acids, and alkaline hydrolysis media; contact with iron or copper surfaces during prolonged mixing can accelerate degradation. Storage is specified at 15–25 °C in a dry, light-protected area; excursions above 40 °C or relative humidity above 60% require retesting before use. These boundaries are based on lot-to-lot review and do not replace finished dosage form stability studies under the registered packaging.
