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Viwit Pharmaceuticals API Site Successfully Passed FDA cGMP On-site Audit with "No Action Indicated" 2024-09-23 14:46:43

From July 15 to 19, 2024, FDA inspectors conducted a five-day on-site cGMP (Current Good Manufacturing Practice) inspection of Viwit Pharmaceuticals Co., Ltd. (referred to as Viwit API manufacturing facility). Recently, the FDA's official website showed that Viwit's API manufacturing facility successfully passed the cGMP on-site audit with a perfect result of NAI, meaning "Zero 483". This is the second time Viwit's API manufacturing facility has successfully passed the U.S. FDA audit, further affirming Viwit’s robust and continuous production management and quality systems.

Viwit Pharmaceutical Co. Ltd. announces exclusive licensing and supply agreement for two Gadolinium based Magnetic Resonance Imaging (MRI) injectable contrast agents in the US. 2024-09-18 09:00:00

Viwit Pharmaceuticals (Viwit), an innovation driven biopharmaceutical and healthcare company has entered into an exclusive licensing and supply agreement with Zydus Lifesciences Ltd.’s wholly owned subsidiary, Zydus Lifesciences Global FZE for Gadobutrol Injection (generic version of GADAVIST) and Gadoterate Meglumine Injection (generic version of DOTAREM) for the US market.

Viwit Pharmaceutical’s Lifitegrast API has completed registrations in both China and the US! 2024-08-14 11:55:51

Recently, Viwit Pharmaceutical’s self-developed Lifitegrast API has completed the registrations in China and the United States. The API registration number is Y20240000726, and the US DMF number is 040172.

Viwit Pharmaceutical's Varenicline Tartrate Tablet receives official approval from South Africa 2024-07-15 10:01:41

Recently, theViwit independently developed smoking cessation drug Varenicline (Tartrate) Tablets, in strengths of 0.5 mg and 1 mg, received the Drug Registration Certificate issued by the South African Health Products Regulatory Authority (SAHPRA).

Viwit Pharmaceutical's Fosaprepitant Dimeglumine API Receives Official Approval from NMPA 2024-07-12 09:12:19

On July 5, 2024, Viwit Pharmaceitical’s independently developed Fosaprepitant Dimeglumine API received the "Notice of Approval of Application for Listing of Chemical APIs" issued by National Medical Products Administration (NMPA). The registration number is Y20220000736, and the notice number is 2024YS00664.

Viwit Pharmaceuticals' Bimatoprost Eye Drops Receive Official Approval by China NMPA 2024-07-09 10:54:01

Recently, Viwit Pharmaceuticals received the "Drug registration certificate" issued by China National Medical Products Administration (NMPA) for Bimatoprost Eye Drops. The approval number is H20244103. This signifies that the product has received official approval for the Chinese market and has successfully passed the generic drug consistency evaluation, thereby becoming the second domestic generic drug of its kind.

Product Pipeline

Product Pipeline

Categories:R&D and Innovation
Time of issue:2020-01-23 00:00:00
Views:0

Description:

Description:

Information

FDF：

Product Name	Main Indication
Clindamycin Phosphate Injection 4ml:0.6g, 2ml:0.3g	Antibacterials
Levofloxacin Hydrochloride Injection 5ml:0.5g, 5ml:0.3g	Antibacterials
Fleroxacin Injection 10ml:0.4g, 10ml:0.2g, 10ml:0.1g	Antibacterials
Azithromycin Lactobionate Injection 5ml:0.5g, 2.5ml:0.25g	Antibacterials
Cefoperazone Sodium and Sulbactam Sodium for Injection 1.0g	Beta-Lactam Antibacterials
Ganciclovir Injection 20ml:0.25g	1. Cytomegalovirus retinitis in immunodeficiency patients (including AIDS patients) 2. Prevent cytomegalovirus infection that may occur in recipients of organ transplants
Pefloxacin Mesylate Injection 5ml:0.4g, 2ml:0.2g	Antiinfectives
Lidocaine Hydrochloride Injection 5ml:0.1g, 20ml:0.4g	Local anesthetics
Lidocaine hydrochloride injection(for solvent) 5ml:10mg, 2ml:4mg	Local anesthetics
Propyl Gallate Injection 5ml:60mg, 10ml:120mg	Anti-thrombotic drugs
Puerarin Injection 8ml:0.4g, 5ml:0.25g	Cerebrovascular and peripheral vasodilators
Marine Injection 5ml:0.6g	Hepatobiliary medication
Vitamin C Injection 5ml:0.5g, 2ml:0.25g, 2ml:0.1g	Scurrvy,various acute and chronic infectious diseases and purpura,chronic iron poisoning,idiopathic methemoglobinemia
Vitamin B12 Injection 1ml:1mg, 1ml:0.5mg, 1ml:0.25mg, 1ml:0.1mg, 1ml:0.05mg	Megaloblastic anemia,and also used for adjuvant treatment of neuritis
Lappaconitine Hydrobromide Injection 2ml:4mg	Moderate or higher pain
Piroxicam Injection 2ml:20mg	Symptomatic treatment for pain and swelling of various arthritis and soft tissue lesions
Aceglutamide Injection 2ml:100mg	Traumatic brain coma, coma caused by neurosurgery, liver coma and hemiplegia, high paraplegia, sequelae of polio, neurological headache and low back pain
Diazepam Injection 2ml:10mg	Hypnotics and Sedatives

API：

Product Name	Main Indication
Varenicline Tartrate	Smoking cessation drugs for adults
Aprepitant	Prevent acute and delayed nausea and vomiting caused by chemotherapy
Fosaprepitant Dimeglumine	Chemotherapy antiemetics
Vildagliptin	Type 2 diabetes
Efinaconazole	Topical triazole antifungal
Gadoterate Meglumine	MRI contrast agent
Gadobutrol	MRI contrast agent
Mirabegron	Symptomatic treatment of urgency, frequency and/or urge incontinence in adults with overactive bladder (OAB)
Luliconazole	Fungal Infections
Atazanavir sulfate	Combination for HIV-1 infection

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