Delving into the Latest Updates on Sandoz (China) Pharmaceutical Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Sandoz (China) Pharmaceutical Co., Ltd. is a Shanghai-based company that specializes in the manufacturing of generic drugs. As a subsidiary of Novartis AG, the organization was established in 2007.

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Synthetic peptide

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Disease Domain	Count

Nervous System Diseases	1
Neoplasms	1
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Synthetic peptide	1

Top 5 Target	Count

SSTR(Somatostatin receptor)	1

主要目的：研究空腹单次口服阿托伐他汀钙片受试制剂（20mg/片；Lek S.A., Strykow）与阿托伐他汀钙片参比制剂（LIPITOR®20mg/片；Pfizer Pharmaceuticals Co.,Ltd.）后阿托伐他汀在中国健康受试者体内的药代动力学行为，评价空腹口服两种制剂间的生物等效性。次要目的：评价中国健康受试者单次口服阿托伐他汀钙片受试制剂和参比制剂后的安全性。

[Translation]

Primary objective: To study the pharmacokinetic behavior of atorvastatin in healthy Chinese subjects after a single oral administration of the test formulation of atorvastatin calcium tablets (20 mg/tablet; Lek S.A., Strykow) and the reference formulation of atorvastatin calcium tablets (LIPITOR® 20 mg/tablet; Pfizer Pharmaceuticals Co., Ltd.) on an empty stomach, and to evaluate the bioequivalence of the two formulations after oral administration on an empty stomach. Secondary objective: To evaluate the safety of the test formulation and reference formulation of atorvastatin calcium tablets in healthy Chinese subjects after a single oral administration.

Start Date06 Jul 2020

Sponsor / Collaborator

Sandoz (China) Pharmaceutical Co., Ltd.

CTR20200246

/ CompletedNot Applicable

中国健康受试者餐后单次口服阿那曲唑片（1mg/片）的开放、随机、两序列、两周期、交叉设计的生物等效性试验

[Translation] An open, randomized, two-sequence, two-period, crossover bioequivalence study of a single oral dose of anastrozole tablets (1 mg/tablet) in healthy Chinese volunteers after a meal

主要目的为：以Salutas Pharma GmbH公司生产的阿那曲唑片为受试制剂（1mg/片），以AstraZeneca Pharmaceuticals LP生产的阿那曲唑片（瑞宁得®，1mg/片）为参比制剂，比较阿那曲唑在中国健康受试者体内的药代动力学（Pharmacokinetics，PK）行为，评价餐后口服两种制剂的生物等效性。次要目的为：评价中国健康受试者在餐后状态下单次口服阿那曲唑片受试制剂和参比制剂后的安全性。

[Translation]

The primary objective is to compare the pharmacokinetic (PK) behavior of anastrozole in healthy Chinese subjects, using anastrozole tablets produced by Salutas Pharma GmbH as the test formulation (1 mg/tablet) and anastrozole tablets (Arimidex®, 1 mg/tablet) produced by AstraZeneca Pharmaceuticals LP as the reference formulation, and to evaluate the bioequivalence of the two formulations after oral administration after a meal. The secondary objective is to evaluate the safety of a single oral dose of anastrozole tablets test formulation and reference formulation in healthy Chinese subjects after a meal.

Start Date04 Jul 2020

Sponsor / Collaborator

Sandoz (China) Pharmaceutical Co., Ltd.

CTR20200431

/ CompletedNot Applicable

健康受试者餐后单次口服两种制剂阿托伐他汀钙片的开放随机两序列四周期完全重复交叉设计的生物等效性试验

[Translation] An open randomized two-sequence four-period completely repeated crossover design bioequivalence study of two formulations of atorvastatin calcium tablets in healthy volunteers after a single oral dose after meal

主要目的：研究餐后单次口服阿托伐他汀钙片受试制剂（20mg/片；Lek S.A., Strykow）与阿托伐他汀钙片参比制剂（LIPITOR®20mg/片；Pfizer Pharmaceuticals Co.,Ltd.）后阿托伐他汀在中国健康受试者体内的药代动力学行为，评价餐后口服两种制剂间的生物等效性。次要目的：评价中国健康受试者单次口服阿托伐他汀钙片受试制剂和参比制剂后的安全性。

[Translation]

Primary objective: To study the pharmacokinetic behavior of atorvastatin in healthy Chinese subjects after a single oral administration of the test formulation of atorvastatin calcium tablets (20 mg/tablet; Lek S.A., Strykow) and the reference formulation of atorvastatin calcium tablets (LIPITOR® 20 mg/tablet; Pfizer Pharmaceuticals Co., Ltd.) after a meal, and to evaluate the bioequivalence of the two formulations after oral administration after a meal. Secondary objective: To evaluate the safety of the test formulation and reference formulation of atorvastatin calcium tablets in healthy Chinese subjects after a single oral administration.

Start Date30 Jun 2020

Sponsor / Collaborator

Sandoz (China) Pharmaceutical Co., Ltd.

100 Clinical Results associated with Sandoz (China) Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Sandoz (China) Pharmaceutical Co., Ltd.

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1

News (Medical) associated with Sandoz (China) Pharmaceutical Co., Ltd.

03 Apr 2024

·www.businesslive.co.za

Aspen expands China interests as Sandoz deal gets green light

Pharmaceuticals and biotechnology major Aspen has finalised the acquisition of Sandoz China, gaining a bigger foothold into the world’s second-largest pharmaceutical market as it steams ahead with its diversification strategy. In a statement on Thursday, Africa’s biggest pharmaceutical manufacturer said that it had received all the necessary regulatory approvals to conclude its acquisition of Swiss drug maker Sandoz’s Chinese subsidiary for up to €92.6m (R1.9bn)...

Acquisition

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100 Translational Medicine associated with Sandoz (China) Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 19 Feb 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

NDA/BLA

1

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