API

API Manufacturers in Europe– Cefa Cilinas Biotics Pvt. Ltd.

Cefa-Cilinas Biotics Pvt. Ltd. is a leading API manufacturers, suppliers, and exporters of API in Europe. With decades of experience in the pharmaceutical sector, Cefa-Cilinas Biotics Pvt. Ltd. has established itself as a market leader in the production of active pharmaceutical ingredients (APIs), offering a broad portfolio ranging from generic APIs to highly complex specialty molecules.

Our best facilities, advanced API production processes, and robust manufacturing practices ensure full compliance with European regulatory standards, including current Good Manufacturing Practices (cGMP) as defined by the European Medicines Agency (EMA) and the European Pharmacopoeia (Ph. Eur.). This rigorous approach guarantees that every API we produce meets the highest standards of quality, safety, and efficacy, establishing us as a trusted partner for pharmaceutical manufacturers across Europe and the global market.

What is an Active Pharmaceutical Ingredient (API)?

Active Pharmaceutical Ingredient (API) is the bioactive active drug ingredient of a drug product which induces the desired pharmacologic effect. API is the active drug ingredient which is used to cure the disease or condition for which the drug would be prescribed. APIs are blended with excipients or inactive ingredients to manufacture the final form such as tablets, capsules, or injectables.

Manufacturing Process of Active Pharmaceutical Ingredients (APIs)

  • Research & Development (R&D): Economical and green processes are characterised by the utilisation of computational modelling, molecular simulation, and bioinformatics based on the purpose of green chemistry.
  • Synthesis or Fermentation: Biotech fermentation or chemical synthesis in the optimal reactor for the molecule is used to achieve high purity and yield.

  • Purification & Isolation: APIs are dried, chromatographed for purification, filtered, and crystallised to prepare them to pharmacopoeial grade (USP, EP, BP).
  • Compliance & Quality Control: Analytical analysis (HPLC, GC-MS, LC-MS, NMR) for GMP, ISO 9001, WHO-GMP, ANVISA, and DMF compliance.
  • Packaging & Supply: APIs are packed in sanitised facilities and supplied by competent supply chains, and custom synthesis, scale-up, and contract manufacturing capabilities are provided.

Types of Active Pharmaceutical Ingredient

With one of the top API manufacturers and suppliers in Europe, our all-kinds of API producers are surrounded by the newest technology formulation like:

  • Paracetamol API Producers: Among the most frequently used analgesic and antipyretic APIs is paracetamol. We produce paracetamol APIs through green synthetic routes and online process monitoring to achieve purity and uniformity. We possess manufacturing facilities along with an international supply chain to emerge as the first preference supplier for different pharma businesses in Europe as well as worldwide.
  • Etoricoxib API Producers Etoricoxib is among the selective COX-2 inhibitors used in the treatment of inflammation and pain. Our best reactors and ongoing synthesis process ensure high purity and yield levels exceeding pharmacopeial standards. Our etoricoxib APIs are therefore extensively used in the production of high-performance anti-inflammatory medicines.
  • Oncology API Manufacturers: Oncology APIs are specialised and high-tech due to their extremely complicated molecular structure. We operate with nanotechnology, high-containment labs, and sophisticated purification methods in the attempt to preserve them, effectively, and in bulk quantities. Oncology APIs from us have extensive uses for targeted anticancer medication as well as precision therapy.
  • Fluconazole API Manufacturers Fluconazole is among the most extensively utilised antifungal APIs that are extensively accepted to treat systemic and surface fungal infections. We possess our best fermentation and crystallization units through which we provide greater bioavailability and purity. We adhere closely to international standards, thus our fluconazole APIs can be used in regulated markets across the globe.
  • Metformin API Manufacturers: Metformin is an oral first-generation antidiabetic pharmaceutical that is highly accessible worldwide. We manufacture high-quality metformin APIs through continuous manufacturing and process design with AI for batch-to-batch quality. Our APIs assist in addressing increased demand for diabetes management solutions in Europe and across the world.
  • Fermentation-Based API Manufacturers Fermentation-based APIs are manufactured via micro-processing and used in antibiotics, hormones, and enzymes. Our best precision fermentation technology and next-generation bioreactors enable us to manufacture APIs with optimum yields and low impurities. Our APIs are strongly vital in biosimilars and biopharmaceuticals and utilised for meeting the new therapeutic needs.

Applications of Active Pharmaceutical Ingredients

As the top API manufacturers and exporters of Europe, our various API manufacturers are newly highlighted and used extensively in various applications such as:

  • Pharmaceutical Formulations: Our APIs are used in the manufacturing of tablets, capsule production, injectables, and topical creams. They increase the effectiveness and bioavailability of the final drug product by providing sufficient particle size distribution and stability. This means improved patient results and therapy performance.
  • Research and Development We enable pharma R&D with superior APIs for preclinical and clinical trials. Our tailored solutions enable drug discovery and formulation development that enables scale-up. This enables innovation and accelerates new therapies to market launch.
  • Contract Manufacturing and CDMO Services One of our Contract Manufacturing Services includes API & Drug Manufacturing, which involves contract manufacturing, scale-up, and custom synthesis. It enables pharma companies to concentrate on their core business and delegate complex manufacturing issues to us. Our adaptable and reliable services are availed by top pharma multinational companies across the world.

Why Cefa-Cilinas Biotics Pvt Ltd?

Partnering with one of the world’s leading API producers, Cefa-Cilinas Biotics Pvt. Ltd. integrates quality, innovation, and reliability at every stage of production. Our Europe-based operations are equipped with advanced automation, AI-driven monitoring systems, and best API manufacturing equipment, ensuring that all products fully comply with the stringent regulatory requirements of the European Union, including EU Good Manufacturing Practices (EU-GMP) and guidelines set by the European Medicines Agency (EMA).

Each batch undergoes rigorous quality control and testing in accordance with European Pharmacopoeia (Ph. Eur.) standards to guarantee consistent, world-class performance.

We invest heavily in research and development, staying ahead of evolving therapeutic needs and regulatory requirements, and continuously innovating our API offerings.

Cefa-Cilinas Biotics Pvt. Ltd. is a well-known API manufacturers, suppliers, and exporters of intermediates in Europe. As manufacturers of oncology APIs and paracetamol APIs, our extensive product line is versatile enough for various therapy areas and international markets.

Our strict adherence to regulatory standards, modern world-class manufacturing plants, and ongoing research and development ensure that we are the first choice of pharmaceutical multinational companies for API and drug manufacturing services excellence. With ongoing upgrades and expansion, we pledge to create global well-being through innovative Active Pharmaceutical Ingredients. Contact us today for more information!

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