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 cGMP manufacturing and warehousing. Amphastar is a state-of-the-art sterile products manufacturer.
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 as well as specialized areas and equipment for the handling and production of cytotoxic oncology drugs. These production areas are supported by microbiology, chemistry, and R&D laboratories, affording Amphastar the ability 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 an internationally licensed manufacturer of sterile injectable pharmaceuticals supplying worldwide markets. These sterile injectables are used with a variety of IMS delivery systems, including prefilled syringes and vials.
IMS aseptic and topical product filling suites for vials and prefilled syringes are equipped with high-speed filling machines.
Like Amphastar, IMS is supported by on-site microbiology, chemistry, plastic molding and rubber molding plants. These resources provide IMS the ability to design, manufacture, assemble, and fill drug delivery systems at one location.
IMS carefully matches the medication with the right delivery system to provide the quality products for both patient and clinician. Investment in training, equipment, R&D and facilities ensure that IMS will meet its commitment to provide the highest quality products and services.
IMS maintains an excellent regulatory/cGMP compliance record and has a wealth of experience in dealing with federal and local regulatory agencies. Our facilities are registered and inspected regularly by the United States Food and Drug Administration (FDA), the United States Drug Enforcement Agency (DEA), and the California State Food and Drug Board.
In 1968, IMS began business with the launch of unit dose emergency drugs.
In 1998, Amphastar acquired IMS from Medeva, PLC, a London based pharmaceutical company.
Armstrong Pharmaceuticals, Inc.
Armstrong Pharmaceuticals, Inc.'s manufacturing facility is located in Canton, Massachusetts. It has a high speed, automated filling and packaging lines that can accommodate a wide array of container and closure combinations and are capable of filling solution and suspension products using cold-filling and pressure-filling techniques. Its commercial packaging equipment has vision systems and bar code readers to ensure component and code verification.
The facility’s 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, packaging line and warehouse.
Armstrong’s QC Analytical Laboratories are equipped to conduct the latest and most sophisticated tests on raw materials and finished products. These laboratories can perform full release and stability tests at room temperature, accelerated and cycling conditions. Quality Control is performed on-line using statistical process control – X-bar and R charts. In addition to the modern analytical instruments, such as GC, HPLC, UV, and FTIR, the R&D Laboratory is equipped with a complete array of inhalation and nasal spray equipment. The highly automated instruments allow Armstrong’s scientists to perform research critical to aerosol and nasal spray products.
In 1955 Armstrong was founded as a manufacturer of specialty aerosol products. At that time, Armstrong produced a wide array of topical, personal care, and pharmaceutical products.
Since 1993, Armstrong has focused exclusively on pharmaceutical products, primarily in the area of inhaled respiratory drugs that are delivered by MDIs.
On October 9, 2003, Amphastar acquired Armstrong.
In line with Amphastar’s R&D background, Armstrong’s pipeline will continue to build upon the substantial experience achieved in the development, manufacture and marketing (mainly in the U.S.) of inhaled respiratory drugs, primarily for bronchial asthma and chronic obstructive pulmonary disease, delivered by MDIs.
At the core of Armstrong’s efforts to grow its respiratory business is its continued investment in manufacturing capacity both for MDIs and nasal spray products.
Amphastar Nanjing Pharmaceuticals
Amphastar Nanjing Pharmaceuticals, Inc., (ANP), located in the Nanjing Economic and Technological Development Zone in Nanjing, Jiangsu Province of China, is an FDA registered manufacturer of active pharmaceutical ingredients (API) and intermediates. The products manufactured at ANP are intended only for use by Amphastar and its wholly owned subsidiaries. This assures that Amphastar maintains traceability and control of its supply chain back to the starting material.
The 43,023 square foot facility is comprised of several buildings that house all operations such as manufacturing and packaging, laboratories, raw material and finished goods warehousing, and distribution. Like Amphastar, ANP is supported by on-site QC chemistry, microbiology and R&D laboratories. These resources provide ANP the ability to develop, perform scale up and manufacture at one location.
ANP strives to maintain an excellent regulatory/cGMP compliance record and has experience in dealing with federal (US) and local regulatory agencies. The facility is registered and has been inspected by the United States Food and Drug Administration (FDA).
Amphastar France Pharmaceuticals
Amphastar France Pharmaceuticals S.A.S. (Amphastar France) is a French corporation with its manufacturing facility located in Eragny-sur-Epte, France.
Amphastar France manufactures and sells recombinant human insulin (RHI) API and porcine insulin API. RHI API manufacturing involves multiple stages of conversion of raw material to the active ingredient form. A portion of the facility is dedicated for the manufacturing process of the porcine insulin API. The facility performs all operation of porcine insulin API from raw material processing to delivery. As with Amphastar’s other subsidiaries, Amphastar France is focused on continuous production quality as well as quality working conditions.
Amphastar France’s facility is regularly inspected by the FDA and the National Security Agency for Medicines and Health Products (ANSM), and the facility has a good standing regulatory/cGMP compliance record. Amphastar intends to continue to leverage the Amphastar France site in connection with its industrial and commercial strategy.
The facility and other assets owned by Amphastar France were acquired in April 2014 from one of Merck Sharpe & Dohme’s businesses (Diosynth France).
New Drug Research Center
New Drug Research Center is 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, as well as new formulations. Many pilot scale studies and pre-clinical studies are performed at this facility. Upon successful pre-clinical studies, the formulation is then transferred to the R&D department at one of the other three facilities (IMS, Amphastar, or Armstrong) for further testing. The facility currently has two buildings housing a number of advanced instruments in the field of analytical testing, in vitro and in vivo testing, and formulation studies.