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India’s Cipla to establish biosimilars facility in South Africa

Indian generics maker Cipla has announced a deal to set up South Africa’s first biosimilars manufacturing facility, at an estimated cost of over US$91 million.

Richter and DM Bio make deal for trastuzumab biosimilar

Hungary-based Gedeon Richter (Richter) announced on 19 October 2016 that it had signed a technology transfer and in-licensing agreement with South Korea-based biologicals specialist DM Bio for the development and commercialization of DM Bio’s trastuzumab biosimilar.

China’s CFDA rejects more than 80% of drug applications

Data released by China Food and Drug Administration (CFDA) revealed that between January 2015 and January 2016, 1,184 drug applications submitted to CFDA were rejected or withdrawn due to incomplete or fraudulent clinical data.

Dr Reddy’s expands collaboration with Amgen in India

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) is expanding its collaboration with US-based biologicals specialist Amgen with an agreement to market and distribute three of Amgen’s biological medicines in India in the therapy areas of oncology and osteoporosis.

Sun Pharma announces Japanese distribution pact with Mitsubishi Tanabe

Sun Pharmaceutical Industries (Sun Pharma) has announced it will transfer marketing authorizations for 14 of its prescription drugs to Mitsubishi Tanabe Pharma (Mitsubishi Tanabe), allowing the company to manufacture and market them in Japan.

Pfizer antibiotics banned across the EU

An inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has resulted in the ban of several drugs produced by a Pfizer manufacturing site in India. 

EMA reports ‘critical deficiencies’ in Chinese API producer Jinan Jinda

A recent European Medicines Agency’s (EMA) follow up on Jinan Jinda Pharmaceutical Chemi Co Ltd (Jinan Jinda) revealed that the Chinese pharmaceutical company is far off meeting EU standards.

Fosun Pharma to acquire Gland in largest acquisition by a Chinese company in India

Shanghai Fosun Pharmaceutical Group Co Ltd (Fosun Pharma) will acquire an 86% stake in Gland Pharma Ltd for an estimated US$1.2–1.5 billion in China’s largest ever takeover of a company in India.

Mylan receives EU go-ahead to purchase Meda, with conditions

The European Commission (EC) has approved the multi-billion dollar acquisition of Swedish specialty pharmaceutical company Meda by Mylan, one of the world’s largest generics and specialty pharmaceutical companies, subject to certain conditions.

Teva to acquire US-based generics maker Anda

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 3 August 2016 that it had entered into a definitive agreement to buy US generics business Anda from Allergan.

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