Tag: API

The Active Pharmaceutical Ingredient (API) is the part of any drug that is active. Some drugs, such as combination therapies, have multiple active ingredients to treat different diseases. While production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries, in recent years many corporations have opted to send manufacturing overseas to cut costs. This has caused significant changes to how these drugs are regulated, with more rigorous guidelines and inspections put into place.
All drugs are made up of two core components: the API, which is the central ingredient, and the excipient, the substance inside the drug that helps deliver the medication to your system. Excipients are inactive substances, such as mineral oil, and not chemically active.
Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand to another. One brand might use one test, another a different one.

AGC will boost its GMP-compliant pharma production

AGC announced a major expansion of facilities at its Chiba Plant that will result in an increase in the company’s GMP-compliant synthetic pharmaceutical intermediate and active ingredient production capacity.

South Korean company acquires AMPAC Fine Chemicals

SK Holdings, the parent company of South Korea’s third-largest conglomerate SK Group, announced that it has acquired a 100 percent stake in AMPAC Fine Chemicals, a US-based contract manufacturer of APIs.

EMA reviews valsartan drugs after detecting an impurity

The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a Chinese pharma company.

Fermion launched a new API manufacturing facility in Finland

Fermion Oy, a privately held Finnish manufacturer of active pharmaceutical ingredients (APIs), has reached a significant milestone in its investment project by entering the commissioning phase of its new plant in Hanko (Finland).

Belarus developed the technology of obtaining povidone iodine

Belarus developed a technology for obtaining a pharmaceutical substance that can be used for manufacturing iodine-based medicines, announced Maria Sekach, Commercial Director of Belaseptika CJSC.

Former chemical weapon destruction plant will become a pharma facility

Moscow Endocrine Plant will acquire all sites of the former enterprise for destruction of chemical weapons in the Bryansk region in Q1 2019 aiming at establishing an affiliate for manufacturing active pharmaceutical substances.

Construction of a new pharmaceutical plant started in Usolye-Sibirskoye

An official ceremony marking the launch of construction was held at the site of future plant for active pharmaceutical substances and finished medicinal products of Pharmasyntez-Chemie in Usolye-Sibirskoye on June 15.

Cambrex will expand its R&D facility in Italy

Cambrex Corporation, the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients, announced that it will expand research and development capabilities at its site in Paullo, Milan, Italy.

AMRI signs a seven-year contract with NIAID

AMRI, a global contract research, development and manufacturing organization, has secured a seven-year contract from the National Institute of Allergy and Infectious Disease, part of the National Institutes of Health, USA.

Supplies of technical API to Russia declined for the first time in three years

In Q1 2018, Russia imported active pharmaceutical ingredients (API) for 22.0 billion rubles. In ruble-denominated terms, the supplies increased by 28% compared to the same period of 2017.

New API manufacturing facility will be established in the Tula region

On the sidelines of 22nd St. Petersburg International Economic Forum, Alexey Dyumin, the Governor of the Tula region, signed an agreement with Mikhail Shibaev, General Director of Efremov-Pharma LLC.

API market is expected to attain a valuation of $219,601.9 by the end of 2023

The report of Transparency Market Agency provides detailed qualitative analysis of the market dynamics that affect the growth of the global market.

Baltfarma may start producing pharma substances in St. Petersburg SEZ in 2021

On May 14, 2018, the expert council of St. Petersburg Special Economic Zone (SEZ) will review a business plan for building a plant to manufacture active pharmaceutical substances at Novoorlovskaya site.

Ardena boosts its API manufacturing capabilities by acquiring Syntagon

Contract development and manufacturing organisation (CDMO) Ardena has acquired Syntagon, a leading contract manufacturer of novel active pharmaceutical ingredients (APIs) and excipients.

AMRI launched its new aseptic API manufacturing line in Spain

The new line was announced in November 2017 and enhances capacity at the site while complementing AMRI’s other aseptic API manufacturing plants in Bon Encontre and Tonneins, France.

Codexis and Porton Pharma Solutions entered a strategic collaboration

drug development
Codexis and Porton Pharma Solutions announced a strategic collaboration to deploy Codexis’ world-leading biocatalyst technology within Porton’s global custom intermediate and API development and manufacturing business.