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Viwit Pharmaceutical's Phenylephrine Hydrochloride Injection Officially Receives Official Approval by China NMPA

Viwit Pharmaceutical's Phenylephrine Hydrochloride Injection Officially Receives Official Approval by China NMPA

Recently, Viwit Pharmaceuticals received ‘Drug Registration Certificate’ issued by China National Medical Products Administration (NMPA) for independently developed Phenylephrine Hydrochloride Injection, the approval number is H20249727. This signifies that the product has received official approval for the Chinese market and been recognized as having passed the generic drug consistency evaluation.

16

2024

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12

Viwit Pharmaceuticals’ Brimonidine tartrate and Timolol maleate eye drops receive Official Approval by China NMPA

Viwit Pharmaceuticals’ Brimonidine tartrate and Timolol maleate eye drops receive Official Approval by China NMPA

Recently, Viwit Pharmaceuticals received the "Drug registration certificate" issued by China National Medical Products Administration (NMPA) for Brimonidine Tartrate and Timolol Maleate Eye Drops. The approval number is H20249650. This signifies that the product has received official approval for the Chinese market and has successfully passed the generic drug consistency evaluation.

04

2024

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12

Viwit's Nitroglycerin Sublingual Tablets Approved by FDA

Viwit's Nitroglycerin Sublingual Tablets Approved by FDA

Recently, Viwit Pharmaceuticals' proprietary developed Nitroglycerin Sublingual Tablets (strengths: 0.3 mg, 0.4 mg, 0.6 mg) received a marketing authorization letter from the US Food and Drug Administration (US FDA), ANDA number: 218583, signifying the product's official approval in the US market.

22

2024

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10

Viwit Pharmaceuticals API Site Successfully Passed FDA cGMP On-site Audit with "No Action Indicated"

Viwit Pharmaceuticals API Site Successfully Passed FDA cGMP On-site Audit with "No Action Indicated"

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.

23

2024

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09

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

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

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.

18

2024

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09

Viwit Pharmaceutical’s Lifitegrast API has completed registrations in both China and the US!

Viwit Pharmaceutical’s Lifitegrast API has completed registrations in both China and the US!

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.

14

2024

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08

Viwit Pharmaceutical's Varenicline Tartrate Tablet receives official approval from South Africa

Viwit Pharmaceutical's Varenicline Tartrate Tablet receives official approval from South Africa

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).

15

2024

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07

Viwit Pharmaceutical's Fosaprepitant Dimeglumine API Receives Official Approval from NMPA

Viwit Pharmaceutical's Fosaprepitant Dimeglumine API Receives Official Approval from NMPA

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.

12

2024

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07

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