Company news-SINOTHERAPEUTICS

2023.06.05

FDA approves SinoT's ANDA application for PREGABALIN EXTENDED-RELEASE TABLETS

Recently，Food and Drug Administration (FDA) approved SinoT’s ANDA（# 214496）application for PREGABALIN EXTENDED-RELEASE TABLETS（82.5 mg, 165 mg, and 330 mg）

2023.06.05

FDA approves SinoT's ANDA application for PREGABALIN EXTENDED-RELEASE TABLETS

Recently，Food and Drug Administration (FDA) approved SinoT’s ANDA（# 214496）application for PREGABALIN EXTENDED-RELEASE TABLETS（82.5 mg, 165 mg, and 330 mg）

2023.05.15

FDA approves SinoT’s ANDA application for Mesalamine, delayed-release tablets

Recently，Food and Drug Administration (FDA) approved SinoT’s ANDA（#217337）application for Mesalamine, delayed-release tablets（1.2g）.

2022.08.25

Saudi SFDA approvals SinoT’s generic drug Posaconazole delayed-release tablets (100mg)

Recently, SinoT’s generic drug Posaconazole delayed-release tablets (100mg) has been approved by Saudi SFDA

2022.08.25

Saudi SFDA approvals SinoT’s generic drug Posaconazole delayed-release tablets (100mg)

Recently, SinoT’s generic drug Posaconazole delayed-release tablets (100mg) has been approved by Saudi SFDA

2022.04.07

The generic drug Posaconazole delayed-release tablets (100mg) Regulatory Approval in Singapore

Recently, SinoT’s generic drug Posaconazole delayed-release tablets (100mg) has been granted approval from the Health Sciences Authority (HSA) in Singapore.

2021.11.02

NMPA approves SinoT’s ANDA application for Bupropion (XL)(150mg,300mg)

Recently, China's National Medical Products Administration (NMPA) approved SinoT’s ANDA application for Bupropion hydrochloride extended-release tablets (XL)(150mg,300mg), this product has already been approved in FDA on August 2017.

2021.08.12

FDA approves SinoT’s ANDA application for PAROXETINE HYDROCHLORIDE，Extended-Release Tablets

On August 11, 2021，Food and Drug Administration (FDA) approved SinoT’s ANDA（#213612）application for Paroxetine hydrochloride extended-release tablets（12.5mg,25mg）.

2021.01.26

NMPA approves SinoT's ANDA application for Posaconazole delayed-release tablets (100mg)

Recently, China's National Medical Products Administration (NMPA) approved SinoT’s ANDA application for Posaconazole delayed-release tablets (100mg), this product has already been approved by FDA on August 2019 as the first generic drug.

2019.08.16

Warmly congratulations to SINOT team for another successfully passing FDA inspection

The US FDA conducted an onsite inspection of our R&D Center located in Shanghai between Aug 12 and Aug 16, 2019.

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FDA approves SinoT's ANDA application for PREGABALIN EXTENDED-RELEASE TABLETS

FDA approves SinoT's ANDA application for PREGABALIN EXTENDED-RELEASE TABLETS

FDA approves SinoT’s ANDA application for Mesalamine, delayed-release tablets

Saudi SFDA approvals SinoT’s generic drug Posaconazole delayed-release tablets (100mg)

Saudi SFDA approvals SinoT’s generic drug Posaconazole delayed-release tablets (100mg)

The generic drug Posaconazole delayed-release tablets (100mg) Regulatory Approval in Singapore

NMPA approves SinoT’s ANDA application for Bupropion (XL)(150mg,300mg)

FDA approves SinoT’s ANDA application for PAROXETINE HYDROCHLORIDE，Extended-Release Tablets

NMPA approves SinoT's ANDA application for Posaconazole delayed-release tablets (100mg)

Warmly congratulations to SINOT team for another successfully passing FDA inspection