We have a cGMP-compliant API manufacturing facility spread across 9, 098 m², strategically located in Ahmedabad, Gujarat, India.
We have a cGMP-compliant API manufacturing facility spread across 9,098 sq. ft, strategically located in Ahmedabad, Gujarat, India. Our state-of-the-art plant is designed to meet global regulatory standards.
This includes scale up and powder processing facility suitable for multi-Kg to
Metric tons production. 78 KL overall reactor volume capacity (Ranges from 0.25 to 5.0 KL).
Dedicated high pressure reaction facility (Hydrogenator) with working capacity starting from 1 L to
2 KL with utility supply in a range of 5˚C to 140˚C. Dedicated scale up facility for manufacturing
of peptides.
Separate bonded storage area for finished products constructed in 600 m2 area.
Separate area for hazardous material handling.
Advanced Infrastructure for Pilot to Commercial Scale Production
Ensuring Precision, Reliability, and Consistent Excellence
Our QC labs are equipped with state-of-the-art apparatus like GC, HPLC, IR, UV, TOC, Stability chambers etc. for sampling, testing, and handing of raw materials and packaging material as per ICH guidelines.
Our dedicated QA team maintains the QMS (Quality Management Systems) which includes, document review, control and issuance, deviations, change controls, validations, qualifications, self-inspection, training, vendor qualification, product release, audit compliance, market complaints, handling of CAPA, OOS and OOT.
We perform long term, intermediate, accelerated and photo stability studies as per ICH guidelines.
Microbiology labs are equipped with state-of-the-art apparatus like, Autoclaves
for media sterilization and destruction, Bio safety cabinets, Laminar air flow, Fogger machine,
Colony counter, etc.
The Microbiology Laboratory plays a pivotal role in ensuring the
microbial quality and safety of pharmaceutical products. It is responsible for detecting,
identifying, and controlling microbial contamination in raw materials, in-process materials, and
finished products. This ensures compliance with regulatory standards such as FDA, EMA, WHO, and
Pharmacopoeia guidelines (e.g., USP, EP, JP).
Few Glimpses
