09

2022

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06

Congratulations for passing the carbocisteine API production resumption inspection

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On June 6, 2022, we successfully pass the resumption of production site inspection and sample inspection by Hubei Provincial Drug Administration. The carbocisteine API produced by our company has finished the record for resumption production, and can be sold in the market again.

 

Carbocisteine, chemical name S-(carboxymethyl) cysteine, is an odorless, white crystalline powder, an expectorant that affects the secretion of bronchial glands at the cellular level, mainly used for the production of preparations such as carbocisteine oral liquid, carbocisteine tablets and carbocisteine granules, which are used to treat patients with thick sputum and difficulty expectorating sputum caused by chronic bronchitis, bronchial asthma and other diseases. The API product can be developed into different dosage forms such as granules, tablets, effervescent tablets, oral solutions, etc., wherein the original inventor of the tablets is SANOFI. In the current, the market is mainly concentrated in Japan, India, Europe and China. As the trend of the ageing population is intensifying, the carbocisteine will show its good application prospects in the future.

 

As a pharmaceutical company specializing in the field of amino acid and derivative APIs, Proudin strictly implements GMP management, strictly controls the process and quality, and continues to produce safe, effective and stable carbocisteine API products. The product quality can meet the standards of the new Chinese Pharmacopoeia, European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP). We also establish more stringent internal control quality requirements for the control of inorganic impurities, related substances and genotoxic risk impurities, to improve the core quality competitiveness of our carbocisteine products.

 

Carbocisteine is one of the products that our company has kept the Approval Number Document of Drug for long. Now we have applied for the production resumption inspection according to the market demand and passed it successfully. As an amino acid derivative API, carbocisteine further enriches our product lines, provides more product selectivities, providing more development opportunities for the company to improve quality and efficiency, activating reserve capital.

 

In recent years, we persist in high-quality development, focusing on products and customers, and is committed to becoming a global mainstream comprehensive supplier of up-market amino acid APIs, integrating with the world's leading production quality management system, continuously improving process and technical levels, and meanwhile continuing to extend downstream customers of amino acid up-market APIs or pharmaceutical intermediates. We continue to center on human health, and works deep and fine to meet the requirements of human beings for a healthy life.