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Amol Biotech Limited

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Manufacturing Plant

Amol Biotech Limited (ABL) is a leading manufacturer of healthcare industry, specialized in manufacturing of granules on wide range of herbals, minerals, vitamins, amino acids and dietary supplements raw material.

Established in Shanghai in 2005 as part of a Group of companies which operate pharmaceuticals and Nutraceutical GMP certified production facilities in US and India, ABL has obtained GMP certificate and Sanitary registration issued by China Commodity Inspection & Quarantine bureau.

The business model is to develop and supply customer specific pharmaceutical, herbal & nutraceutical products with an emphasis on quality control and customer service.

ABL not only aims to provide quality products to the global market, but also aspires to create an environment in which to foster and cultivate talent and encourage innovations. For this purpose, the company can rely on a comprehensive research and development division, which is an integral part of the production process. The company joined Biofarma Group in 2023.

Facility Facts

Distinctive technology: granulations

The company has a long and consolidated experience in the production of granulations, offering innovative and high-quality solutions for the nutraceutical sector. Granulation, in fact, is a key technique for the creation of nutritional supplements of various kinds, such as multivitamins, herbal extracts, protein powders and amino acids. ABL process involves meticulous mixing of the active ingredients with selected excipients, such as fillers and binders, followed by precise granulation using state-of-the-art machinery. The resulting granules are then compressed, resulting in tablets or capsules of the highest quality, ready to meet the needs of consumers.

Le mini-tabs, tecnologia realizzata da US Pharma Lab, parte di Biofarma Group

Technology advantages:

  • Enhanced physical properties, such as density & uniform particle size distribution

  • Directly compressible ingredients help improve hardness & friability- ideal for high-speed tableting

  • Reproducible flow behavior to eliminate batch-to-batch variation & produce consistent tablet weight 

For ingredients difficult to compress or posing hygroscopicity problems, ABL proprietary technology“N-CAP+®” improves:

  • Particle size distribution

  • Bulk and tapped density

  • Flow characteristics

  • Content uniformity

  • Compressibility

Analytical expertise

Amol Biotech Limited stands for excellence in analysis and quality control, offering highly specialised services to ensure product compliance and safety. Detailed analyses are performed according to the major international pharmacopoeias (USP, EP, BP, JP, ACS, CP) on herbs, amino acids, vitamins, minerals and other products, whether raw, intermediate or finished.

For non-pharmacopoeia products, in-house validated and standardised test methods are used.

ABL also has extensive experience in the development of advanced analytical methods, including trace metal and vitamin analysis by AAS and HPLC, and offers method validation studies according to ICH Q2B guidelines to ensure reliability and accuracy.

Shelf life and stability studies, including accelerated and real-time studies, follow ICH Q1 guidelines, while impurity analysis is performed in accordance with ICH Q3 guidelines. Finally, the company offers comprehensive support for nutritional labelling of food and supplement products.

ABL Highlights

Certifications

  • Registration Certificate for Export Food Production Enterprise

  • NSF GMP Registration program requirements of NSF/ANSI 455-2 - 2021 (21 CFR Part 111, 21 CFR Part 117, 21 CFR Part 11, 21 CFR Part 1.5 Subpart L & 21 CFR Part 1.9 Subpart O)

  • Intertek GMP 21 CFR Part 210 & 211 (2020)

Production capabilities

  • Solid food supplements

Contacts

8138 Daye Road, Punan Machinery and Electronics Industral Park, Fengcheng Town, Fengxian District, Shanghai 201409, China

Tel.: 021-57559415

E-mail: amol@amolbiotech.com.cn

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© Biofarma Srl C.F. and P.IVA 02895910301
T. +39 0432 868711 F. +39 0432 868018
Via Castelliere, 2
33036 Mereto di Tomba (UD) Italy
Number REA UD - 296214
Date of entry in the
Business Register of UDINE: 01/07/2017
Registration number: 02895910301
Share capital euro 3.000.000