ShangPharma opens pilot plant in Shanghai

Published: 17-Jan-2011
Design & Build Manufacturing Regulatory Research & Development Cleaning Analysis Pharmaceutical

For pharma development and cGMP manufacturing

ShangPharma Corporation, a China-based contract research and manufacturing organisation, has started operations at a new manufacturing facility in the Shanghai suburb of Fengxian.

The new multi-purpose pharmaceutical development and cGMP manufacturing facility will allow ShangPharma to support its clients Phase II and Phase III trials, expanding its service offering to include process and formulation r&d, analytical method development and validation, and cGMP manufacturing of intermediates and APIs.

Previously the CRO/CMO provided clients with materials for early discovery and GLP toxicology testing and Phase I clinical trials.

ShangPharma said it might further expand its manufacturing facilities if there is demand for commercial manufacturing of FDA- or EMEA-approved drugs.

The Fengxian facility will operate as a wholly owned subsidiary of the company under the name China Gateway Pharmaceutical Development Co. It includes a pilot plant that supports six separate bays with reactor capacities ranging from 200 to 3,000 litres and other speciality bays with reactor capacities ranging from 50 to 2000 litres for high temperature, cryogenics, highly toxic and pressurised reactions, including hydrogenation.

The company said there are also two cleanroom suites rated at Class 100,000 for isolation, 10 kilo-lab suites for bothnon-cGMP and cGMP manufacturing, as well as a large r&d laboratory for analytical, formulation and process development activities.

In addition, there are separate buildings for utilities, materials management, warehouse storage and waste water treatment with room for further expansion to support commercial manufacturing activities.

Testing of raw materials, intermediates and final products will be carried out at the site. An independent quality assurance department will ensure that materials are manufactured in accordance with cGMP requirements and that established standard operating procedures are followed, the firm said.

See more

You may also like

Research & Development

Med Uni Graz researchers present a new approach to targeted therapy for leukaemia

Read more
Acute myeloid leukaemia (AML) is a cancer of the haematopoietic cells that causes the uncontrolled proliferation of certain immature blood cells

Trending Articles

  1. Manufacturing Chemist Stand Side with GEA and Hovione We discover what exhibitors at CPHI 2025 are showcasing LIVE!
  2. Thermo Fisher Scientific Expands Gibco Bacto portfolio Its next-generation, chemically defined media will boost E. coli biomanufacturing productivity, helping innovators scale plasmid DNA and protein production with confidence
  3. FDA considers black box warning for COVID-19 vaccines amid internal disputes The US FDA is reportedly weighing a black box warning for COVID-19 vaccines — a move that has alarmed public health leaders and vaccine manufacturers, who say no new safety signals support such action
  4. Romaco Holding GmbH Romaco is a leading international supplier of machinery and integrated system solutions for the development, production and packaging of pharmaceuticals, nutraceuticals, food, cosmetic and chemical products. All from a single source.

Upcoming event

From powder to granules: a deep dive into wet granulation methods

14 January 2026 | Virtual See all

You may also like

Research & Development

Med Uni Graz researchers present a new approach to targeted therapy for leukaemia

Acute myeloid leukaemia (AML) is a cancer of the haematopoietic cells that causes the uncontrolled proliferation of certain immature blood cells
Manufacturing

When science meets security: the future of small molecule outsourcing

Looking across 2025 and into 2026, chemical and pharmaceutical manufacturing is navigating a period of rapid transition, with trends emerging that will influence competitiveness for years to come
Research & Development

Research shows that Pepaxti is effective in high-risk myeloma

Oncopeptides announces new research demonstrating that Pepaxti (melflufen) maintains its anti-myeloma activity in patients with high-risk genetic features, including deletion 17p (del(17p)) and TP53 mutations
Research & Development

Biologics at a turning point: complexity, AI and the road to 2026

Despite rapid change, the growing complexity of biologics and the rise of AI-driven design are reinforcing the increasing need for deep scientific expertise and innovation leadership, says Campbell Bunce (CB), Chief Scientific Officer at Abzena
Regulatory

Grifols receives US FDA approval for new fibrinogen concentrate: FESILTY (fibrinogen, human-chmt)

The fibrinogen concentrate complements Grifols’ bleeding management portfolio, expanding therapeutic options for patients
Regulatory

Hansa Biopharma submits BLA to FDA for Imlifidase in desensitisation for kidney transplantation

Imlifidase is an enzyme that rapidly and efficiently cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly to inhibit IgG-mediated immune response
Manufacturing

The story of an East-West German company | 150 years of Romaco Kilian

Kilian’s story tells of the rise, fall and resurgence of a Berlin company steeped in tradition, which is now based in Cologne. It is the story of the entrepreneur Fritz Kilian, who turned a small locksmith’s workshop in Berlin into a successful company that is still a leading manufacturer of tablet presses today. It is the story of a visionary whose legacy has endured the test of time and continues to this day
Subscribe now