About Rom Re Ro Munteanu Srl - Steron Products Supplier in Oman

Oman hosts Rom Re Ro Munteanu Srl, an imported‑tier supplier that currently lists five active products. The catalogue comprises the items Steron FVII, Steron f VIII, Steron FIII, Steron FIVbp and Steron FIV. Each entry is recorded without additional HS‑code information, indicating a focus on specialized biomedical materials rather than bulk commodities. The supplier’s trust tier is classified as “harbor,” which signals a moderate level of verification within the platform’s rating system. No further corporate history, employee numbers or production capacity are provided in the source data.

The five Steron products correspond to recombinant clotting factors commonly designated as Factor VII, Factor VIII, Factor III, and two variants of Factor IV. In the pharmaceutical sector these biologics are typically supplied in lyophilized or liquid form for intravenous infusion. Activity is expressed in International Units (IU) per vial, and purity levels above 95 % are standard for regulatory approval. Storage requirements generally include a frozen or refrigerated cold chain, with shelf‑life specifications ranging from 12 to 24 months depending on the formulation.

Product Range and Specialties of Rom Re Ro Munteanu Srl

Rom Re Ro Munteanu Srl’s catalogue lists five distinct recombinant clotting factor products. Within the biopharmaceutical trade, such factors are classified under HS chapter 30 (specifically 3002.90 for human blood‑derived products and related biotechnological preparations). Typical industry grades include high‑purity, GMP‑manufactured batches where specific activity is measured in IU/mg and endotoxin levels are limited to <0.5 EU/mL. Buyers often request data on viral inactivation steps, buffer composition, and stability at −20 °C or 2‑8 °C for liquid formulations. The Steron line aligns with these conventions, offering products that meet the purity and activity benchmarks required for clinical use.

In broader market practice, recombinant clotting factors are produced using mammalian cell culture systems and must comply with pharmacopoeial standards such as USP <795> for sterile products. Common specifications include protein concentration between 10‑30 mg/mL, pH adjusted to 6.5‑7.5, and osmolarity near 300 mOsm/kg. Packaging typically involves glass vials or pre‑filled syringes, each sealed to maintain sterility and protect against temperature excursions during transport.

Trade and Export Information - Rom Re Ro Munteanu Srl

Oman’s biotechnology export profile includes a limited but growing segment of high‑value biologics, with recombinant proteins often routed through specialized freight forwarders to maintain a continuous cold chain. International buyers of clotting factors are concentrated in the European Union, North America, and the Gulf Cooperation Council, where hemophilia treatment programs drive demand. HS code 3002.90 is the primary tariff entry for these products, and many importing jurisdictions require a Certificate of Origin, a GMP compliance certificate, and a detailed product specification sheet before customs clearance. Export documentation frequently references WHO pre‑qualification or EMA/US‑FDA approval status, even when the supplier itself does not hold those authorizations.

Logistically, 20‑foot refrigerated containers (often termed “reefers”) are standard for bulk shipments, while smaller orders are packed in insulated boxes with dry ice or gel packs to sustain temperatures below −20 °C. Incoterms such as CIF or DAP are commonly applied, with the exporter responsible for arranging temperature‑controlled transport to the port of entry. Buyers typically inspect the shipment for temperature logger records and verify that the batch number matches the accompanying Certificate of Analysis.

Sourcing from Rom Re Ro Munteanu Srl - Buyer Guidance

When sourcing Steron clotting factors, buyers should request a current GMP certificate, the latest batch Certificate of Analysis, and detailed stability data covering the intended storage temperature range. Verification of viral clearance steps, such as solvent/detergent treatment or nanofiltration, is also standard practice for biologics of this class. Prior to order confirmation, it is prudent to obtain a sample for independent potency testing (e.g., clotting assay) and to confirm that the supplier can meet cold‑chain logistics for the full transit duration.

Typical minimum order quantities for recombinant factors range from 10,000 IU to 100,000 IU per batch, depending on the factor and formulation. Lead times of 4‑8 weeks are common, reflecting cell‑culture production cycles and the need for rigorous quality release testing. Buyers should also confirm packaging specifications - such as vial size, closure type, and inclusion of temperature monitoring devices - to ensure compliance with downstream handling requirements.

What product codes does Rom Re Ro Munteanu Srl list for clotting factors?

The catalogue includes Steron FVII, Steron f VIII, Steron FIII, Steron FIVbp and Steron FIV, each representing a recombinant clotting factor variant.

Which HS code is applicable to these products?

Recombinant clotting factors fall under HS chapter 30, most frequently recorded under code 3002.90 for human blood‑derived or biotechnological preparations.

What certifications should a buyer request before purchasing?

Buyers should ask for a current Good Manufacturing Practice (GMP) certificate, the batch Certificate of Analysis, and any relevant regulatory approvals such as WHO pre‑qualification or EMA/US‑FDA clearance.

Are there specific storage conditions for the Steron products?

These biologics are normally stored frozen at - 20 °C or refrigerated at 2‑8 °C, with stability data provided for each formulation to guide handling.

What typical unit of measure is used for these clotting factors?

Activity is expressed in International Units (IU) per vial, and purity is generally reported as a percentage exceeding 95 %.

What packaging and shipping methods are standard for these items?

Cold‑chain packaging such as insulated boxes with dry ice, gel packs or refrigerated containers is standard, and shipments are often arranged under CIF or DAP Incoterms to ensure temperature control.

What is a common minimum order quantity for recombinant clotting factors?

Minimum orders usually start at 10,000 IU per factor, though exact quantities depend on the specific product variant and buyer requirements.

How long does it typically take to receive an order after placement?

Lead times of 4 to 8 weeks are typical, reflecting the time needed for cell‑culture production, purification, and comprehensive quality release testing.