A roundup of developments and latest news from China (iBio, CC-Pharma), Japan (Neopharma, Lupin) and United States (Glenmark, Strides Pharma).

China

iBio and CC-Pharming Expand Business Collaboration in China

iBio, a plant-based contract developer and manufacturer of biopharmaceuticals, has expanded the scope of its business venture with CC-Pharming, a plant molecular medicine technology and development company, by granting it a royalty-bearing commercial license to iBio’s bio-better rituximab product candidates for the territory of China. In addition, iBio will grant a research license to CC-Pharming for iBio’s FastPharming System, processes for plant-based production, and information for the evaluation of multiple product opportunities.

Rituximab was first approved by the US Food and Drug Administration for the treatment of certain B cell non-Hodgkin lymphomas. Its clinical uses have expanded over time to encompass treatment for chronic lymphomatic leukemia as well as a range of autoimmune diseases, including certain types of rheumatoid arthritis.

The commercial license provides CC-Pharming with iBio’s FastPharming System to develop rutuximab. iBio says FastPharming System combines plant protein expression, automated hydroponics, and glycan engineering technologies to deliver gram quantities of biologics for research or further manufacturing uses. The license allows CC-Pharming to be responsible for the development, launch and commercialization of iBio’s bio-better rituximab in China, including costs associated with the marketing and sales of the licensed product. Under the license, iBio retains all rights to commercialize iBio technology-based products in markets outside of China.

Both companies plan to develop additional products for the Chinese market in other product categories, particularly research and clinical reagents, non-pharmaceutical skincare products, and botanical derivatives.

Source: iBio

Japan

Neopharma Group Acquires Kyowa Criticare Injectable Business in Japan

Neopharma Group, an Abu Dhabi, United Arab Emirates-based branded, generics and active pharmaceutical ingredients manufacturer, has acquired the Japanese injectable business and related assets belonging to Kyowa Pharmaceutical Industry, a subsidiary of Lupin Limited. Neopharma has acquired all the issued and outstanding share capital in Kyowa Criticare Co. Ltd from Lupin through its Japanese subsidiary, neoALA.

With the acquisition, Neopharma gains a plant and associated facilities based out of Atsugi, Japan. The facilities have been engaged in the sale and contract manufacturing of injectable products.  

Neopharma says the facility acquisition is part of its global expansion drive. Currently, Neopharma manufactures and supplies active pharmaceutical ingredients and finished dose formulations in more than 50 markets.

Source: Neopharma Group

United States

Glenmark Recalls More Than 31,000 Tubes of Antifungal Cream

Glenmark Pharmaceuticals, a Mumbai, India-based pharmaceutical company, is voluntarily recalling 31,224 tubes of clotrimazole and betamethasone dipropionate antifungal cream (USP, 1%/0.05%, 15-gram tubes, Rx only) in the US due to complaints received of liquidy texture.

The Class III recall was initiated August 7, 2019. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Source: US Food and Drug Administration

Strides Pharma Acquires Micelle BioPharma’s Soft-Gel Capsule Mfg Facility in Florida

Strides Pharma Science, a Bangalore, India-headquartered pharmaceutical company, through its subsidiary Strides Pharma, has acquired a soft-gel capsule manufacturing facility in Riviera Beach, Florida for $500,000 from Micelle BioPharma, a developer of lipophilic compounds.

Strides says it will invest up to $10 million to build incremental capabilities and add additional dosage formats for select large-volume products. The facility can manufacture products with formulations with containment needs and is an integrated manufacturing–packaging soft-gel facility.

Strides now has eight formulation sites globally. Strides has annual capacity of more than 2 billion soft-gel capsules at its site in Bangalore, India.

Source: Strides Pharma Science