“Our Founder member and VINSON of Lincoln pharmaceuticals ltd Shri Rajanibhai G Patel has given direction to the company over last four decades. A vision that has breathed life in our Mission to heal and protect lives of billions of hearts across the world. Lincoln has grown and evolved over various type of drug products.
Now under the guidance of Shri Rajanibhai Patel, we are proud to announce the launch of API Division of Lincoln pharmaceuticals ltd. The idea of launch of API Division is to strengthen the quality and foothold of Lincoln pharmaceuticals ltd across the globe.”
Overview
LPL an established presence in API Manufacturing with focus in products of various therapeutic segments like – anticholinergic Anaesthetics Anti-Allergic, gynaecology, benzodiazepines, Epilepsy, antispasmodic, 5-HT3 receptor antagonists etc
We take pride in setting the products, processes and the systems as per the industry standards and in making continuous improvement to deliver quality products. Our facility is delineated areas for warehouse, QA, QC, R & D, production and finished products.
The plant has current capacity of1.5 MT per year.
we have strong Backed by R&D, Core business is driven by Ethical values and EHS standards. Our focus is to develop advance APIs and their Intermediates.
Research and Development
LPL, many hazardous processes are performed at commercial scale which are developed in R&D and successfully scaled up. The complex chemistries are performed in addition to the following range:
- Friedel Craft’s Acylation
- Claisen Condensation
- Grignard Reaction
- Mannich Reaction
- Ritter Reaction
- ESTERIFICATION
The current activities include
- Process development of generic APIs and Intermediates
- Route scouting, process research for Custom Synthesis and manufacturing products
- Life-cycle management of existing products
- Development of non-infringing processes
- Trouble-shooting support to plant
- Providing support to QA for Regulatory filing.
Manufacturing facilities
LPL has state-of-the-art manufacturing facilities located in AHEMEDABAD.
- Multiple product manufacturing facility to cater market demand.
- Capability to handle controlled drug substances.
- Backward integration of key starting materials
All Manufacturing facilities include well delineated areas for :
- QC (Instrumental, Chemical & Microbiology)
- QA
- Dedicated Manufacturing Areas with multiple clean Rooms
- Engineering & Maintenance
- Warehouse
- Materials & Finished Goods Stores
- In-house Microbiological laboratory
Quality Assurance Policy
As a manufacturer of bulk drugs, intermediates , we at LPL, have a moral and social responsibility to ensure the highest quality from process to product. We are committed to driving the growth of our organisation by continually enhancing customer satisfaction, by providing a safe and congenial working environment to employees and by treating suppliers as business partners.
Quality Assurance
AT LPL we take our commitment to Quality very seriously. Every plant has well defined processes and systems in place, to comply with Current Good Manufacturing Practices (cGMP) laid down by Schedule M, Schedule L, ICH Q7 and TRS guidelines.
Well-defined Standard Operating Procedures (SOPs) and protocols have been documented and implemented for our quality system based on the various guidelines laid down by regulatory bodies WHO, with global standards.
- Our processes , cleaning , analytical method transfers & technology are all validated by regulatory authorities.
- All Vendors and Contract Laboratories are subject to the most demanding global quality standards.
- However , our toughest challenge is to meet our own internal Quality Standards. We set the bar for ourselves much higher than those set by International Regulatory bodies
Quality Control
- A dedicated Quality Control Department is committed to setting the gold standard for quality in every aspect- processes , systems and products.
- The Laboratory is equipped with Ultra-modern & Sophisticated High precision instruments like – GC – HS, HPLC with PDA and UV Detectors, Spectrophotometers, Digital Polarimeter, UV Spectrophotmeter, FTIR, ATR, Auto Titrators, Karl Fischer, IR moisture balance, ETC.
- The complex includes a Microbiology & Endotoxin testing Laboratory
- Stability chambers for stability monitoring as per ICH guidelines 25°C-60%RH, 30°C- 65%RH , 35°C- 75%RH & 40°C-75%RH, 60°C
- Reserve sample management: Storage area with controlled room temperature (Below 25°C).
Our Strength
- At the core of our success , is our committed and dedicated staff.
- Every Team member is trained and qualified to play specialised roles in various functional areas
- Regular training programmes and workshops are conducted to expose them to rapidly evolving global technological changes
- Attractive career & growth opportunities keep the team energised and inspired
- A range of welfare measures keep the team motivated and contented
