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인도네시아 고객만을 위한 공지 사항  View details
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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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API

API

DKSH는 글로벌 선도 공급업체로부터 고품질 원료의약품(API)을 제공합니다. 다양한 치료 분야에서 제약사의 규제 준수, 안전성 및 일관된 제형 성능을 지원합니다.

API

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BILASTINE

Bilastine is a white to off-white crystalline powder that is sparingly soluble in methylene chloride and practically insoluble in acetone. It has an assay range of 98.0% to 102.0%.

 

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

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.

BUTAMIRATE CITRATE

Refarmed Chemicals is proud to present its esteemed pharmaceutical compound, Butamirate Citrate, an integral antitussive agent designed to alleviate discomfort in patients suffering from dry, unproductive coughs. Our Butamirate Citrate is an optimal choice for those grappling with upper respiratory tract infections, bronchitis, pneumonia, and even asthma, providing relief from persistent coughing that often accompanies these conditions. Crafted with meticulous attention to quality, our Butamirate Citrate appears as a white to yellowish powder with a slightly waxy texture, assuring ease of incorporation into various dosage forms. Its chemical identity is confirmed through rigorous testing, including the citrate and IR tests, maintaining a high level of purity and performance. The compound exhibits excellent solubility, being freely soluble in water and ethanol (96%), which ensures flexibility in formulation. Adhering to the gold standard of production, Butamirate Citrate holds GMP certification and is characterized by a precise pH range of 3.5 to 4.0. Our commitment to safety and efficacy is evidenced by the thorough analysis that guarantees an assay value between 98.0% - 102.0%, with minimal impurities. Heavy metals content is strictly controlled to ensure patient safety, and residual solvents such as Isopropanol, MTBE, Isopropyl ether, and Toluene are meticulously regulated. Our Butamirate Citrate operates by targeting the cough center in the medulla oblongata to effectively suppress cough reflexes, without reliance on opioids. This action provides a duration of relief for 4-8 hours, allowing for a more comfortable recovery process for the patient. It is suitable for adults and children over the age of 6, with dosage adjustments available to accommodate individual patient responses and tolerability. In conclusion, Refarmed Chemicals' Butamirate Citrate stands as a testament to our dedication to delivering pharmaceutical ingredients of the highest caliber. Our product not only meets the robust demands of the pharmaceutical industry but also provides a critical component for the formulation of efficacious cough suppressants that cater to a wide range of patients.

 

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

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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