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.

Dr. Reddy’s to sale its API manufacturing business unit in India

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Dr. Reddy’s Laboratories entered into a definitive agreement for the sale of its API manufacturing business unit to Therapiva Private, an emerging generics pharmaceutical company.

BioDuro created new drug discovery center for chemistry and biology

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BioDuro, a leading global life sciences contract research and development organization announced that it has established a new drug discovery center for chemistry and biology in San Diego (USA).

Lonza launches its new HPAPI suites in Switzerland

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Lonza (Switzerland), a specialty CDMO, announced an expansion of its highly potent API (HPAPI) capacity for the specific support of antibody drug conjugate (ADC) payload manufacturing. This latest ...

Cambrex sets up a center of excellence for API clinical supply

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Cambrex Corporation, the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), and finished dosage forms announced that it is to establish a center of ...

Evonik expands its contract manufacturing capabilities

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Evonik, a global CMO leader for API and advanced intermediates, announced the completion of a €36 million expansion of its contract manufacturing capabilities in the U.S. and Europe.

Lonza initiated a pharmaceutical early-intermediates supply initiative

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The initiative leverages chemical production facilities at the company’s Visp (Switzerland) site to address increasing global early-intermediates supply security and quality concerns.

Chinese API manufacturer refused admittance to EU inspection

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European medicines regulators have issued a notice that an ingredient for a generic brain cancer drug made in China does not meet manufacturing standards, after inspectors were refused entry.

Italian API manufacturer buys a production facility in India

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Olon, an API contract development and manufacturing organization and generics supplier, announced the acquisition of a local generics chemical operations API manufacturing facility in Mahad, India.

European CRO Nuvisan acquires parts of Galderma R&D capabilities

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The NUVISAN GROUP signed an agreement with NESTLÉ SKIN HEALTH/ GALDERMA to take over parts of the R&D capacities in Sophia-Antipolis (France).

KBI Biopharma launched a subsidiary in Belgium

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KBI Biopharma announced that its subsidiary KBI Biopharma BVBA has begun operations at its newly completed laboratories in Leuven, Belgium.

AMRI will manufacture cannabinoid-based API for Nemus Bioscience

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Nemus Bioscience announced an agreement with AMRI for the development and manufacture of Nemus’ proprietary cannabinoid-based active pharmaceutical ingredients (API).

Cambrex broadens its capabilities by acquiring Halo Pharma

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Cambrex Corporation announced it has entered into a definitive agreement to acquire Halo Pharma, a leading dosage form CDMO for approximately $425 million.

AGC will boost its GMP-compliant pharma production

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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

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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

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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

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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).