All state-of-the-art facilities follow the highest cGMP/GCP/GLP standards.
Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc. (Amphastar) is located in Rancho Cucamonga, California, just 40 miles east of Los Angeles. The majority of this facility is dedicated to sterile injectables cGMP manufacturing.
Amphastar has a variety of manufacturing and production capabilities, including automated and validated high-speed vial and prefilled syringe production lines, which include lyophilization capabilities. These production areas are supported by microbiology, chemistry, and R&D laboratories, allowing Amphastar to develop and produce solutions, emulsions, suspensions, and lyophilized products.
International Medication Systems, Ltd.
International Medication Systems, Ltd. (IMS) is located in South El Monte, California. It is a CGMP manufacturer of sterile injectable pharmaceutical products. The sterile injectables are configured in vials, syringes, and prefilled syringes.
IMS aseptic and topical product filling suites for vials and prefilled syringes are equipped with high-speed filling machines.
IMS is supported by on-site microbiology, chemistry, plastic molding, and rubber molding plants. These resources allow IMS to design, manufacture, assemble, and fill drug delivery systems at one location.
As the innovator of Critical Care drugs (CCD) in prefilled disposable syringes, IMS CCD products have become the industry standard supply for emergency use.
Amphastar acquired IMS from Medeva, UK, in 1998.
Armstrong Pharmaceuticals, Inc.
Armstrong Pharmaceuticals, Inc. is located in Canton, Massachusetts. It has high-speed, automated filling and packaging lines for inhalation products, which can accommodate various container and closure combinations and fill different dosage forms using pressure-filling techniques. Its commercial packaging equipment has vision systems and bar code readers to ensure component and code verifications.
The current configuration supports the production of both Metered Dose Inhalers (MDIs) and nasal spray products.
Armstrong’s state-of-the-art facility houses the analytical and R&D laboratories, production lines, and warehouses.
Amphastar acquired Armstrong in 2003.
In 2018, Armstrong received FDA approval for Primatene MIST®, the only FDA-approved asthma inhaler available OTC.
In line with Amphastar’s R&D background, Armstrong’s pipeline will continue to build upon the substantial experience in inhaled respiratory drugs delivered by MDIs and nasal sprays.
Amphastar Nanjing Pharmaceuticals
Amphastar Nanjing Pharmaceuticals, Inc. (ANP), located in the Nanjing Economic and Technological Development Zone in Nanjing, Jiangsu Province of China, is a US FDA-registered manufacturer of active pharmaceutical ingredients (API) and intermediates. The products manufactured at ANP are primarily used by Amphastar and its subsidiaries. This allows Amphastar to maintain traceability and control of its supply chain back to the starting material.
ANP possesses all operations such as manufacturing and packaging, laboratories, raw material and finished goods warehousing, and distribution. ANP is supported by on-site QC chemistry, microbiology, and R&D laboratories.
ANP strives to meet or exceed the US FDA expectation and maintain an excellent regulatory/cGMP compliance track record.
Amphastar France Pharmaceuticals
Amphastar acquired Amphastar France Pharmaceuticals (AFP) in April 2014. AFP has its manufacturing facility in Eragny-sur-Epte, France.
Since the acquisition, Amphastar successfully constructed the upstream insulin manufacturing process to supplement the existing downstream process for manufacturing recombinant human insulin (RHI) API. In addition, AFP has a long history of manufacturing porcine insulin API. AFP’s production is supported by on-site QC chemistry and microbiology laboratories.
With a joint effort of the Amphastar team in the US, the AFP R&D crew actively builds its pipeline of biopharmaceutical products.
The US FDA and the National Security Agency for Medicines and Health Products (ANSM) regularly inspect the AFP facility. The facility has an excellent standing regulatory/cGMP compliance record.
New Drug Research Center
New Drug Research Center, located in Chino, California, is a wholly owned subsidiary of Amphastar Pharmaceuticals, Inc. Its function is to conduct preliminary studies for complex generic and new drugs. Starting from new formulations, many pilot scale studies and pre-clinical studies are performed at this facility. As soon as the confirmation of the pre-clinical studies is successful, the formulation is transferred to the appropriate Amphastar R&D department for further development. The facility houses numerous advanced instruments in analytical testing, in vitro and in vivo testing, and formulation studies.