Unlike most independent API manufacturers, whose facilities are often designed with standard fittings purchased from pharmaceutical or specialty chemical companies, Benzochems dedicated facilities, located in the Tarapur & Mahad were specifically designed incorporating the best features of modern API facilities.
The design concepts of each facility has been developed in-house, with specialist project engineers headed by Technical Director & safety of personnel & material, the Q7A guidelines for man & material movement, dedicated intermediate & separate final molecule areas with clean rooms have been incorporated in each facility.
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All our Facilities are USFDA/ EUGMP compliant
The Conceptual designs of each of our facilities were reviewed & approved by USFDA Consultant & permanent member of Benzochem’s “Core Scientific Advisory Team “
Benzochem’s Modern Cytotoxic APIs Manufacturing facility was audited & Approve by EU QP auditors.
The Basic concept adopted in all our facilities has been to build separate buildings for Intermediate & final molecule manufacturing which eliminates all possibilities of contamination.
Niche APIs Facility (Plot no 81-82) MIDC -Tarapur
This is Benzochem’s oldest Manufacturing facility which commenced production on June 22nd 1978. It was refurbished as per ICHQ7A guidelines in 2005 . The facility has received satisfactory audit results from 15 major international customers. The broad array of chemical reactors ranging from very small to very large provides the flexibility to conduct a wide variety of chemical processes. This offers the capability to meet customers' requirements in any size range. All phases of operations will adhere to stringent international quality, environmental, health and safety requirements and will be in full compliance with international cGMP standards.
Oncology APIs Facility ( Plot no 64 ) MIDC Tarapur
Benzochem Modern Cytotoxic/ Oncology APIs facility is located adjacent to Niche APIs manufacturing facility Reactor sizes range from 50 liters to 5,000 liters and materials range from stainless to glassed-lined to hastelloy. Separate Intermediates Manufacturing Suites Two units For Manufacturing bulk APIS and two units for manufacturing Kilo level APIs are present in this unit. Four lines are capable of cytotoxic/high potency production with total containment and properly segregated air and physical systems. All lines have their own dedicated filtration/drying/milling/and packaging facilities. Several multiple-use drying and finishing units are available to reduce intermediate bottlenecks and all have been validated for API/cGMP operations. All process and utility systems are fully automated using SCADA systems .
Anti Malarial Facility ( K4/1) Additional Mahad MIDC
This Facility is spread over 50,000 Sq meters area at Mahad MIDC making it one of the largest Quinine manufacturing Facility in South East Asia. Separate Buildings for extraction lines & Final molecule Manufacturing eliminate contamination .The broad array of chemical reactors ranging from very small to very large provide the flexibility to conduct a wide variety of chemical processes. This offers the capability to meet customers' requirements in any size range. All phases of operations will adhere to stringent international quality, environmental, health and safety requirements and will be in full compliance with international cGMP standards. |
