At MEGGLE Excipients, we strive to exceed expectations in everything we do. For over 70 years, we have been providing the pharmaceutical and nutraceutical markets with a broad-based lactose portfolio unmatched in the industry. Our portfolio covering solid dosage forms such as tablets, capsules, sachets, powder formulations, and dry powder inhalation.
Experience, Consistency and Highest Standards – In order to guarantee optimum quality and batch-to-batch consistency, we develop all our own products and manufacture most of them in-house. A few of our products are made under strict oversight and to our exacting quality standards by contract manufacturers in Europe. We make sure all international quality standards are met or exceeded. This is one of the many reasons why leading global pharmaceutical and supplement manufacturers have chosen us as a supplier.
70 YEARS
Experience Highest quality since 1950
100 %
Quality management Exceeds international standards
100 %
Customer service Dedicated experts and two production sites
„Our top priority is to continually guarantee our customers the best possible quality.“
Matthias Gschwendtner, Director Quality
Topics of interest
Pharmacopoeias
MEGGLE offers alpha-lactose monohydrate grades that comply with Ph. Eur., USP-NF, JP, and the Chinese Pharmacopoeia (ChP). The anhydrous lactose product, DuraLac® H, also meets these pharmacopoeial standards. MEGGLE produces several co-processed excipients:
Cellactose® 80 (75% lactose monohydrate and 25% powdered cellulose) MicroceLac® 100 (75% lactose monohydrate and 25% microcrystalline cellulose), StarLac® (85% lactose monohydrate and 15% maize starch), CombiLac® (70% lactose monohydrate, 20% microcrystalline cellulose, and 10% maize starch), and RetaLac® (50% lactose monohydrate and 50% hypromellose), all adhering to harmonised pharmacopoeial monographs. All these products have undergone pharmacopoeial harmonisation.
Drug Master Files
US – Drug Master Files (DMFs) A Drug Master File (DMF) is a confidential document submitted to the FDA by pharmaceutical manufacturers and for some products Excipient manufa, detailing facilities, processes, and materials used in drug production. It ensures the FDA has necessary information while protecting proprietary data. We provide DMFs to support regulatory compliance and approval.
Chinese – Drug Master Files (cDMFs) Similarly, a China Drug Master File (cDMF) meets Chinese regulatory requirements and is managed by the National Medical Products Administration (NMPA). Our Shanghai office can assist with cDMF-related matters to ensure compliance with Chinese regulations.
MEGGLE: EXCiPACT certified since 2014
At MEGGLE, we take pride in being a pioneer in pharmaceutical excipients and were the first to achieve the EXCiPACT certification in 2014. This certification is crucialfor ensuring the quality and safety of pharmaceutical excipients. Regulators accept third-party auditing for excipients if the certification body is credible and uses qualified auditors. EXCiPACT, a non-profit organization, manages this certification scheme globally.
By maintaining our EXCiPACT certification, MEGGLE demonstrates its commitment to the highest standards of manufacturing and distribution, ensuring trust and reliability for our customers.
Contact us if you are interested in the certificate or the audit report.
MEGGLE has created an Excipient Information Package (EIP) based on the “IPEC Excipient Information Package (EIP): User Guide and Template, 2020” to provide standardized information. The primary aim of this guide is to standardize data exchange between excipient suppliers and users, simplifying the information exchange process.
By using this format, suppliers can efficiently respond to requests and provide consistent information, while users can anticipate the standard data they will receive. The MEGGLE EIP includes three documents: Product Regulatory Datasheet, Manufacturing Site Quality Overview, and Site and Supply Chain Security Overview.
MEGGLE is governed by a large set of Management Standards that guide our day-to-day activities and help us implement our issue-based management policies:
ISO 9001: Quality
ISO 14001: Environment
ISO 45001: Health and Safety
ISO 50001: Energy
Sedex Member and SMETA 4-Pillar-Audit
IPEC-PQG GMP Guide: Pharmaceutical Excipients
EXCiPACT: GMP and GDP for Pharmaceutical Excipients
Explore our comprehensive range of pharmaceutical excipients designed to meet the highest standards in formulation performance. From oral solid dosage forms to inhalation applications – we offer reliable solutions for every challenge.
Not sure which excipient fits your formulation best? Use our Product Configurator to find the most suitable solution based on your application and requirements.
From formulation support to process optimization – discover how MEGGLE’s experts help turn your technical challenges into efficient, reliable solutions.
Explore our global network of application labs, where advanced technologies and expert teams turn formulation challenges into innovative excipient solutions.
Discover how MEGGLE combines pharmaceutical excellence with environmental and social responsibility – and how our actions today shape a healthier tomorrow.
