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Layanan Pengaduan Konsumen

(Business Unit Performance Materials, Sales Support Team)

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Gedung AIA Central, Level 39, Jl. Jend. Sudirman Kav. 48A, Jakarta Selatan, Indonesia

+62 21 2988 8557

[email protected]

Direktorat Jenderal Perlindungan Konsumen dan Tertib Niaga Kementerian Perdagangan Republik Indonesia
0853 1111 1010

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DEXMEDETOMIDINE HCL

Dexmedetomidine Hydrochloride (HCl) stands as a pivotal chemical for the pharmaceutical sector, utilized primarily as a sedative, anxiolytic, and analgesic agent. Under the umbrella of performance materials, this product maintains a strong presence within medical settings, with a focus on providing sedation for non-intubated patients before and/or during surgical and other procedures. It's also used in intensive care sedation for intubated, mechanically ventilated patients. Manufactured in adherence to stringent standards, Dexmedetomidine HCl is a white or almost white powder that dissolves freely in DMSO and is slightly soluble in methanol and water, ensuring its ease of adoption in various pharmaceutical formulations. Our product complies with the United States Drug Master File (US DMF), and proudly carries the European Union Good Manufacturing Practice (EU GMP) certification, attesting to its high-grade quality and the thoroughness of its production process. Beyond its uses, this product is defined by its anatomical therapeutic chemical classification, which refers to a system used for the classification of drugs. A prime focus is on organic purity, with individual impurities like Dimethylphenylethyl imidazole and Levomedetomidine meticulously controlled to exceed pharmacopeial standards. Our product boasts a laudable enantiomeric purity and an assay value ranging between 98.0% and 102.0%, exemplifying its consistency and reliability. It is vital to note that our Dexmedetomidine HCl maintains permissible thresholds for residual solvents, ensuring the safety and efficacy of the drug. The list of related substances and required specifications for solvents like acetone, ethanol, and benzene are rigorously quantified below recognized safety limits, aligning with the highest regulatory expectations. We ensure that each batch is synonymous with excellence, a testament to our unwavering commitment to the highest quality standards in pharmaceutical ingredients. By choosing our Dexmedetomidine HCl, stakeholders in the pharmaceutical industry can confidently incorporate a product that is not only potent and versatile but also conforms to the critical parameters of drug safety and manufacturing excellence. For more information, please visit our website or contact our customer service team, who stand ready to assist with product inquiries and logistic details.

 

Products still subject to third-party patent protection might be available solely for R&D purposes.

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CIPROFIBRATE

Refarmed Chemicals presents Ciprofibrate, a crucial pharmaceutical material developed for clinical efficacy in managing lipid disorders. Developed with the utmost precision, Ciprofibrate is a fibrate-class drug specially formulated as a therapeutic agent to regulate high levels of cholesterol and triglycerides, factors leading to cardiovascular diseases. Our product is synthesized with rigorous compliance to quality standards, evidenced by its Good Manufacturing Practice (GMP) certification. The drug appears as a white or slightly yellow-white crystalline powder, indicative of its purity. Highly soluble in anhydrous ethanol and toluene yet practically insoluble in water, Ciprofibrate facilitates flexibility in pharmaceutical formulation, allowing for both tablet and capsule dosage forms in strengths of 100mg and 200mg. Targeting primary hypercholesterolemia (type IIa or IIb), mixed dyslipidemia, and as preventive treatment against cardiovascular events in high cholesterol patients, Ciprofibrate's composition facilitates the acceleration of cholesterol and triglyceride breakdown and removal from the body. Recommended for bi-daily intake alongside meals, the treatment's efficacy is augmented by adherence to healthy lifestyle choices, including a balanced diet and regular exercise. Safety parameters dictate careful administration especially to those with a history of gallbladder disease, and periodic liver function evaluations are advised. Contraindications include severe renal or hepatic conditions, pregnancy, breastfeeding, or known hypersensitivity to fibrates. Consultation with healthcare professionals is critical when concomitant medications are involved, particularly statins, anticoagulants, and antibiotics. Storage requirements for Ciprofibrate are straightforward — room temperature conditions away from light and moisture ensure stability. As a product from the storied catalogue of Refarmed Chemicals, now part of the DKSH Group, Ciprofibrate is accompanied by dependable documentation for Detailed and Master Files, affirming its reputable standard in pharmaceutical resources.

 

Products still subject to third-party patent protection might be available solely for R&D purposes.

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PIZOTIFEN MALATE

Pizotifen Maleate, presented by Refarmed Chemicals, is an instrumental pharmaceutical agent aiding in the management of several health conditions. Its primary use is in the prevention of migraines, a debilitating headache disorder known to impair the quality of life. Furthermore, it serves as a reliever for vestibular disorders, which include symptoms such as vertigo, dizziness, and tinnitus. In addition to these, Pizotifen Maleate has proven effective in treating pruritus, chronic itching skin conditions, and acts as an adjunctive therapy for asthma, providing relief from respiratory discomfort. Manufactured under stringent quality control conditions in India, Pizotifen is carefully crafted into tablets with dosages of 5 mg and 10 mg to accommodate varying therapeutic needs. The active ingredient is a histamine antagonist, functioning by obstructing histamine receptors in the body, hence mitigating inflammation and associated symptoms like itching. It is essential to note that while Pizotifen Maleate is generally well tolerated, common side effects might include drowsiness, dizziness, dry mouth, nausea, and occasional headaches. Due to its drowsing effects, this medication should be used cautiously, particularly when concentration is required, such as in driving or operating heavy machinery. Exercise caution before using Pizotifen Maleate if any of the following conditions are present: glaucoma, prostate enlargement, narrow-angle glaucoma, or any known hypersensitivity to the drug. Additionally, individuals with liver or kidney complications should consult their healthcare provider before commencing treatment. Stored ideally at room temperature, Pizotifen Maleate should be shielded from light and moisture. Full efficacy may take several weeks to establish, making it imperative to adhere to the prescribed dosage regime. In the occurrence of severe adverse effects, the treatment should be discontinued, and medical advice must be sought immediately. Each batch of Pizotifen Maleate undergoes rigorous testing ensuring a high purity—exemplified by the specifications pertaining to solubility, identification tests, and the stringent control over impurities. Your corporate clients can trust in the quality sustained by EU GMP certification, as reflected in the clear documentation and reliable manufacturing processes. Choosing Pizotifen is investing in a pharmaceutical product that is as dedicated to patient wellness as it is to consistent product integrity.

 

Products still subject to third-party patent protection might be available solely for R&D purposes.

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ATORVASTATIN CALCIUM

Atorvastatin Calcium, provided by Refarmed Chemicals, is a potent pharmaceutical ingredient used by healthcare professionals in the management and prevention of several cardiovascular-related conditions. As an integral part of the statin class of medications, Atorvastatin Calcium serves a critical role in reducing cholesterol levels, specifically low-density lipoprotein (LDL) cholesterol, apolipoprotein B, and total cholesterol. It is also effective in lowering triglyceride levels and is indicated for the prevention of cardiovascular events such as ischemic strokes and transient ischemic attacks, particularly in patients who are at high risk of these events. This product is especially valuable for the treatment of familial heterozygous and homozygous hypercholesterolemia. However, it is contraindicated in individuals with known hypersensitivity to the active ingredient, those suffering from active liver disease, and should not be used during pregnancy and breastfeeding due to potential risks. Formulated as a white or almost white yellowish crystalline powder, Atorvastatin Calcium comes with comprehensive documentation and certifications, such as the Certificate of Suitability (CEP) and Good Manufacturing Practice (GMP) standards, ensuring its quality and safety. The material's purity is rigorously controlled, with an assay requirement of 98.0% to 102.0%, minimal water content, and strict limits on enantiomer impurities as well as residual solvents such as Methanol and Methyl tert-butyl ether, as specified in the provided image of its typical properties. Patients prescribed Atorvastatin Calcium should be under close medical supervision to monitor liver function and signs of muscle damage, a potential adverse effect. Muscle pain, diarrhea, nausea, headache, and flatulence are among the commonly reported side effects. Moreover, Atorvastatin Calcium can interact with several other medications, necessitating careful review by healthcare professionals when determining a patient's regimen. Refarmed Chemicals' rigorous adherence to quality and patient safety, as exemplified by their Atorvastatin Calcium product, fulfills the expectation of effectiveness and reliability desired by healthcare providers and wholesalers looking to distribute a product that can make a significant impact on public health.

 

Products still subject to third-party patent protection might be available solely for R&D purposes.

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