API Manufacturing
MANUFACTURING AT ALKEM ACTIVA
Pioneering Excellence In Production
Welcome to Alkem Activa's Manufacturing division, where pharmaceutical innovation converges with cutting-edge production capabilities. Our approach to pharmaceutical manufacturing is underpinned by a relentless pursuit of excellence and unwavering commitment to delivering high-quality pharmaceutical products.
Our Approach: Quality is Our Benchmark
In the realm of pharmaceutical manufacturing, quality is paramount. At Alkem Activa, we understand the pivotal role that manufacturing plays in delivering safe, reliable, and efficacious medications to patients. Our approach is centered on maintaining stringent quality control measures throughout the manufacturing process, backed by the seal of approval from the U.S. Food and Drug Administration (USFDA), World Health Organisation Good Manufacturing Practice (WHO GMP), Ministry of Food and Drug Safety (MFDS) and Therapeutic Goods Administration (TGA), Australia.
USFDA-Approved Facilities: A Commitment to Excellence:
Our manufacturing facilities are equipped with state-of-the-art machinery and technology, ensuring precision manufacturing of pharmaceutical products. They have earned the prestigious recognition of USFDA approval. This certification reflects our unwavering dedication to quality, safety, and adherence to global regulatory standards.
Efficiency and Innovation: Striving for Perfection:
Efficiency and innovation are at the core of our manufacturing processes. We continuously seek opportunities for improvement, whether it's optimizing production workflows, reducing energy consumption, or implementing emerging technologies to stay at the forefront of the pharmaceutical manufacturing industry. Our USFDA-approved facilities exemplify this commitment to excellence.
OUR MANUFACTURING CAPABILITIES
500 KL + reaction volume across 2 USFDA approved manufacturing facilities in India and 1 manufacturing facility in California, USA with flexibility to scale up further as needed
Wide range of modern analytical instrumentation used for reaction monitoring and product analysis including HPLC, GCMS, LCMSMS, & Ion Chromatography, GC, XRPD, and IR
Equipped with award winning Process Safety Risk Assessment tools & procedures including MT RCI, Fauske, ARSST, DSC, TGA, & CHETAH software
Mandva Site, India
- cGMP compliant multipurpose plant with 3 dedicated modules
- Alkylation/Acylation Bromination Oxidation Reduction Nitration Condensation Reactions
- Manufacturing facilities for peptide molecules
- SS & GL reactors up to 10KL capacity
- Dedicated facility for hydrogenation using 500L & 2000L stainless steel reactors
- Temperature controlled design to manage run-away reactions
- Capability to handle reactions from -25˚C to 250˚C
- Solvent recovery plant with distillation capacity of 30KL/ day
- Inspected by US FDA
Site also has a 200MT/month fructo-oligosaccharides manufacturing facility
Ankleshwar Site, India
- cGMP compliant multipurpose plant with 3 dedicated modules
- SS, GL, & Hastelloy reactors 30L to 4KL capacity
- Containment facility & facilities for plant scale column chromatography & controlled crystallization
- Temperature controlled design to manage run-away reactions
- Capable of handling chlorination, bromination, sulfonation, reductive amination, esterification & chiral synthesis
- Inspected by US FDA, MFDS Korea, TGA Australia