One Boisar site. Forty-plus countries.

Mac-Chem's Boisar (Tarapur MIDC) manufacturing site anchors direct domestic supply in India and WHO-regulated export across the rest of Asia.

• India GMP Certificate , India Verified

  Food & Drugs Administration, Maharashtra State (India)

  Bulk Drugs / API (Schedule M).

• WHO-GMP Certificate , Global / WHO member states Verified

  CDSCO / Maharashtra FDA (WHO-GMP format)

  Covers 109 approved products for WHO-regulated tenders and rest-of-world export.

• ISO 14001 & ISO 45001 , India Verified

  Bureau Veritas Certification

  Environmental and occupational health & safety management, site-wide.

Counts pending Domestic manufacture and wholesale supply run under the India GMP certificate; country-level registration status for other Asian markets is shared with partners on request.

EU and Swiss regulatory clearance opens Mac-Chem's Suxamethonium Chloride supply into European markets, backed by a written confirmation for EU API import.

• EDQM Certificate of Suitability (CEP) , European Union Verified

  European Directorate for the Quality of Medicines & HealthCare (EDQM)

  CEP 2012-025, Suxamethonium Chloride.

• Swissmedic GMP Compliance Certificate , Switzerland Verified

  Swissmedic, the Swiss Agency for Therapeutic Products

  CH23-0006, Suxamethonium Chloride.

• CDSCO Written Confirmation , European Union Verified

  Central Drugs Standard Control Organisation (CDSCO), India

  WC-0275, covers 35 APIs exported to the EU.

Counts pending EU and Swiss market access runs through the CEP, the GMP compliance certificate, and the Written Confirmation on file; product-level dossier status is shared with partners on request.

Latin American supply runs under Mac-Chem's WHO-GMP certification, with dossiers developed for out-licensing as partners register locally.

• WHO-GMP Certificate , Global / WHO member states Verified

  CDSCO / Maharashtra FDA (WHO-GMP format)

  Supports WHO-regulated tenders and rest-of-world export, including Latin America.

Counts pending Country-by-country registration in Latin America is led by the partner, supported by dossiers Mac-Chem develops for out-licensing.

African supply runs under the same WHO-GMP certification, with CPhI Middle East & Africa a standing point of contact for regulatory and procurement teams.

• WHO-GMP Certificate , Global / WHO member states Verified

  CDSCO / Maharashtra FDA (WHO-GMP format)

  Supports WHO-regulated tenders and rest-of-world export, including Africa.

Counts pending Country-by-country registration in Africa is led by the partner, supported by dossiers Mac-Chem develops for out-licensing.