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Quality & Regulatory
Every accreditation on this register is issued and renewed independently by its own regulator, against Mac-Chem's manufacturing facility at MIDC Tarapur, Boisar, Maharashtra, not against any single product.
6 documented accreditations · India GMP · WHO-GMP · EDQM CEP · Swissmedic · CDSCO Written Confirmation · ISO 14001 / 45001
6
Accreditations on record
6
Confirmed from certificates on file
2010
Founded
41
R&D scientists
Accreditation register
Mac-Chem's Boisar facility holds six documented manufacturing accreditations, each confirmed from the issued certificate held on file: an India GMP certificate from the Maharashtra FDA, WHO-GMP certification, an EDQM Certificate of Suitability (CEP), a Swissmedic GMP compliance certificate, a CDSCO Written Confirmation for EU API export, and ISO 14001 / ISO 45001 certification for environmental and occupational health-and-safety management. Each carries issuing body, scope, site, and validity where the certificate states it.
European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe
Swissmedic, the Swiss Agency for Therapeutic Products
CDSCO / Maharashtra FDA (WHO-GMP format)
Central Drugs Standard Control Organisation (CDSCO), India
Bureau Veritas Certification (UKAS accredited)
Food & Drugs Administration, Maharashtra State (India)
Pending approval Further national approvals are on record and being digitized for publication with the same level of certificate detail.
Market access
Regulatory affairs teams read this register as a market-access map, not a trophy wall. The six accreditations group into three tracks: EU and regulated export, WHO-regulated / rest-of-world export, and domestic supply.
The EDQM Certificate of Suitability (CEP 2012-025) and the Swissmedic GMP compliance certificate (CH23-0006) open Switzerland and EU-linked supply, and the CDSCO Written Confirmation (WC-0275, 35 APIs) satisfies the EU's Written Confirmation requirement for API import under Directive 2001/83/EC.
WHO-GMP certification, issued in the CDSCO / Maharashtra FDA WHO-GMP format and covering 109 approved products, supports WHO-regulated tenders and rest-of-world API export.
The India GMP certificate from the Maharashtra FDA (Bulk Drugs / API, Schedule M) anchors domestic manufacture and wholesale supply, backed site-wide by ISO 14001 and ISO 45001 certification for environmental and occupational health-and-safety management.
Each certificate is scoped to the Boisar site's quality systems and process controls. It does not itself constitute approval of any individual product, and every underlying product registration still depends on its own dossier being filed and maintained in that market.
Certificate detail
The India GMP certificate (Maharashtra FDA, certificate 6134110) covers Bulk Drugs / API manufacturing under Forms 25 (KD/715) and 28 (KD/506), valid through May 2029. WHO-GMP certification covers 109 approved products across lyophilized/powder injectable and cytotoxic and general APIs, valid through January 2028. The EDQM CEP (2012-025, Suxamethonium Chloride) followed an EDQM inspection in October 2023 with attestation in March 2024. The Swissmedic GMP compliance certificate (CH23-0006, Suxamethonium Chloride) followed the same October 2023 inspection and was issued in February 2024. The CDSCO Written Confirmation (WC-0275) covers 35 APIs exported to the EU and is valid for three years from May 2024. ISO 14001:2015 and ISO 45001:2018 (Bureau Veritas, certificate IND.24.2007/IM/U) were issued in December 2024, valid through December 2027.
Product quality
Formulation manufacturers, distributors, and regulatory affairs contacts can raise a certificate, batch, or dossier query through the Contact page. Each query is logged and routed to the regulatory affairs contact responsible for the market in question. Mac-Chem does not make, and this page does not imply, any claim about the safety or efficacy of a finished drug product; certification and query-handling statements here describe manufacturing quality systems and process controls only.
Pending approval A named quality-management-system framework and formal SOP references are pending company confirmation and are not published here until verified.
