Mac-Chem Products (India) · est. 2010
The API behind
the injectable.
A specialist manufacturer of oncology, sterile and general active ingredients — pioneers in lyophilization, trusted across 40+ regulated markets.
- Oncology API
- Lyophilized Bulk Sterile API
- General API
- DMF · CEP
Boisar · Tarapur MIDC, India
Why Mac-Chem
We manufacture the active ingredients other companies choose not to — the sterile, cytotoxic, and structurally complex molecules that demand dedicated containment, freeze-drying precision, and process chemistry most API makers avoid.
The portfolio
Three segments, one Boisar site
63 marketed active ingredients across three segments, each built around a distinct manufacturing discipline.
- 01
Oncology API
33 marketed · 10 in development
15,000 kg/yr installed capacity
Cytotoxic and targeted-therapy actives, made under Cat III/IV containment and glove-box technology.
- 02
Lyophilized Bulk Sterile API
15 marketed · 2 in development
15,000 kg/yr installed capacity
Freeze-dried sterile actives across multiple lyophilizers, including 140 L and 400 L units — the lyophilization specialization.
- 03
General API
15 marketed · 5 in development
10,000 kg/yr installed capacity
Non-sterile, non-oncology active ingredients, made on the same CGMP-compliant Boisar floor.
How it's made
Built for the molecules that need containment
Multiple lyophilizers — including 140 L and 400 L units — run alongside eight stainless-steel and six glass-lined reactors and steam and dry-heat sterilizers. A dedicated Cat III and IV containment facility, with glove-box technology for cytotoxic substances, is controlled through fully automated, GAMP-compliant systems.
Liquid
Sterile solution filled
Frozen
Crystallized below −40 °C
Lyophilized cake
Sublimed, sealed, stable
On record
6 accreditations, documented
Every entry is confirmed from the certificate held on file — agency, reference, and jurisdiction, nothing embellished.
- 01 On file
European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe — European Union
CEP 2012-025
- 02 On file
Swissmedic, the Swiss Agency for Therapeutic Products — Switzerland
Compliance Certificate CH23-0006
- 03 On file
CDSCO / Maharashtra FDA (WHO-GMP format) — Global / WHO member states
WHO-GMP · 109 approved products
- 04 On file
Central Drugs Standard Control Organisation (CDSCO), India — India
Written Confirmation WC-0275 · 35 APIs
- 05 On file
Bureau Veritas Certification (UKAS accredited) — India
ISO 14001:2015 / 45001:2018
- 06 On file
Food & Drugs Administration, Maharashtra State (India) — India
GMP Certificate 6134110
Where it ships
Present across 40+ regulated markets
Dossiers developed for out-licensing across Asia, Europe, Latin America, and Africa, with a presence built at CPhI (Japan, China, South-East Asia, Korea, Middle East & Africa, Worldwide, India) and Asia Pharma Expo Bangladesh.
- Asia
- Europe
- Latin America
- Africa
40+
Countries
6
Accreditations
41
R&D scientists
Partner with Mac-Chem
Oncology, sterile, and general API supply — talk to us about dossiers, capacity, and regulatory filings.