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Layanan Pengaduan Konsumen, PT DKSH Indonesia,

(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

Explore DKSH's range of high-quality APIs sourced from leading global suppliers. We help pharmaceutical companies worldwide ensure compliance, safety, and consistent formulation performance across diverse therapeutic applications.

API

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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.

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.

EMEDASTINE DIFUMARATE

Refarmed Chemicals presents Emedastine Difumarate, an exemplary antihistamine pharmaceutical agent meticulously designed to grant symptomatic relief for individuals battling allergic conjunctivitis. As a testament to its efficacy, Emedastine Difumarate operates as a selective blocker of histamine H1 receptors, adeptly preventing the histamine-induced dilation of blood vessels and curbing mast cell degranulation. Crafted as an ophthalmic solution, the medicine should be administered with precision—1 drop into each affected eye, twice daily—to ensure optimal results. The product is characterized by its white to yellowish powder form, testament to its purity and the high standards of manufacturing. Typically soluble in water and sparsely soluble in anhydrous ethanol, the product maintains a clean and uncolored appearance in the solution with a pH range carefully maintained between 3.0 to 4.5. In compliance with rigorous industry standards, Emedastine Difumarate proudly bears EU GMP certification, guaranteeing its production under the highest quality management protocols. Furthermore, it is crucial to note that the product is strictly contraindicated for individuals with known hypersensitivity to its components and should be avoided by those with narrow-angle glaucoma. Utilization of Emedastine Difumarate may lead to temporary blurred vision and other minor visual disturbances; hence, caution is advised while engaging in tasks necessitating sharp vision post-application. Moreover, it's celebrated for its well-tolerated nature, with minimal side effects, predominantly confined to the ocular region such as itching or burning sensations, and less commonly systemic effects like headache or fatigue. Our product ensures a safe storage parameter within room temperature (20-25°C) and gives due attention to light protection, thereby maintaining its integrity. With Emedastine Difumarate, Refarmed Chemicals delivers an established, profound solution for alleviation from the discomfort caused by allergic conjunctivitis, steering toward better ocular health for patients worldwide.

 

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

LEVETIRACETAM

REFARMED CHEMICALS proudly introduces Levetiracetam, a versatile antiepileptic medication essential for the management of seizure disorders. This innovative product is formulated to provide relief for individuals suffering from partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. Recommended for both adults and children, Levetiracetam is an indispensable pharmaceutical geared towards enhancing the quality of life for patients aged 6 years and older. Crafted with utmost precision, Levetiracetam is available in tablets, oral solution, and intravenous solution, delivering flexibility and convenience in administration. The active ingredient binds to synaptic vesicle protein 2A within the brain, mitigating the release of neurotransmitters that incite seizures, thereby providing effective seizure control with a reliable and targeted mechanism of action. REFARMED CHEMICALS, a global pharmaceutical leader situated in Mexico City, adheres to the highest standards of quality and efficacy. With rigorous certifications, including GMP and WC, our Levetiracetam meets and exceeds industry specifications. The product presents as a white or almost white powder, demonstrating high solubility in water among other solvents, ensuring ease of formulation into various dosages. While side effects such as somnolence, asthenia, and dizziness can occur, Levetiracetam remains a top choice for patients and healthcare providers alike. The prudent approach to treatment involves discussing potential interactions with other medications and considering precautions, particularly for those with kidney conditions. Our commitment to delivering high-caliber, affordable medical solutions is unrivaled. Levetiracetam from REFARMED CHEMICALS, both in generic and brand formulations, signifies our dedication to empowering healthcare professionals and patients with reliable, accessible, and high-quality therapeutic options. Trust in REFARMED CHEMICALS – your partner in progressive healthcare solutions.

 

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

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