100 ml bottle into box and then into cartons.
Customised packing available.
Nhavasheva or Mumbai Air
Bilirubin is formed by the breakdown of haemoglobin in the spleen, liver and bone marrow. It can be conjugated with glucuronic acid or unconjugated (albumin bound). An increase in bilirubin concentration in the serum or tissue is called jaundice and can occur in toxic or infectious diseases of the liver. High levels of conjugated or direct bilirubin indicate that bile is not being properly excreted; therefore an obstruction may be present in the bile duct or gall bladder. High levels of unconjugated bilirubin indicate that too much haemoglobin is being destroyed or that the liver is not actively treating the haemoglobin it is receiving.
We are highly sophisticated and professional manufacturers of Clinical Chemistry Reagents, Rapid Immunoassays, Urine Tests Strips, Immunology reagents, Dyes and Stains for Fluorometry and many others. Every product we develop, we keep in mind how we would help spread the confidence of an accurate diagnostic report to the Medical Practitioner as well as to the Patient. It is because of this goal at our hearts, we believe in adding value to the product to remain competitive and improve our Value Proposition.
We have a state-of-the-art production facility of around 27,000 square ft. located in Palghar (Near Mumbai), Maharashtra, India which is just 100 km away from ChhatrapatiShivaji International Airport, Mumbai, India. The location is well connected to Rail, Road, Sea and Air for multiple modes of transportation of products. The entire facility has been certified by Food and Drugs Administration (Schedule M), Government of India. Our facility is GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) certified. All operations are governed through ISO 9001:2015 and ISO 13485:2003 Quality Management Systems. The latest equipments and infrastructures empowers the manufacturing of 2000 liters of liquid reagents being taken up from formulations to bottling as final product on daily basis. Current plant capacity from raw materials to finished goods exceeds 3 million tests/day. The entire manufacturing process is done is controlled environment of humidity, particle-free zones and class 10,000 production rooms. Systems and multiple auto-check points have helped ALPL to run 4 different production lines simultaneously with zero error to achieve maximum production.
CHAIRMAN AND MANAGING DIRECTOR
Mr. Mahendra Dashora holds Master of Science in Chemistry (1979) and Master of Science in Biochemistry (1981) from the prestigious Maharaja Sayajirao University of Baroda (M.S.U), Vadodara, Gujarat (India). He has over 36 years of vast experience in the field of In Vitro Diagnostic (IVD) industry. He is the promotor of Anamol Laboratories Pvt. Ltd. and is a true visionary. He has 3 years (1981-1984) of exposure at Bayer Diagnostics (now Siemens Ltd.) as Chief Scientific Officer and In-charge of Quality Assurance.
He co-founded Accurex Biomedical Pvt. Ltd. in 1984 and took the responsibility of Director – Technical for 20 years. He was solely responsible for the development and manufacturing of all the products at Accurex. After parting with Accurex in 2004, he took over 100% shares of Anamol Laboratories Pvt. Ltd. and started the manufacturing facility at the present location.
He is certified ‘APPROVED MANUFACTURING COMPETANT PERSON’ by Dept. of Food and Drug Administration (FDA).
At Anamol, his manufacturing capabilities and standardization grew in the fields of Immunology as well (Rapid Immunoassays, ELISA, CLIA, etc.)
Some of his achievements include:
1. First time indigenously manufactured enzyme based lyophilized Clinical Chemistry kits in India (1984).
2. First time indigenously manufactured liquid stable Clinical Chemistry reagents in India (1992).
3. First time indigenously manufactured Urine Test Strips in India (1984).
His passion to learn and zeal to make the most complex technologies available for the common mass brings a lot of wisdom in the organization.
We are the original manufacturers of the following products. We have a great experience and understanding of
Latex and Turbidimetry
Rapid Test Kits
Controls and Calibrators
Innovative Products according to the customer requirements
HOW WE BUILD QUALITY?
At Anamol Laboratories Pvt. Ltd., we believe quality is a result of a series of well-planned actions to achieve a specific objective. In case of diagnostic test system, the ultimate purpose is patient benefits and affordability. Our role as a manufacturer is critical as any manufacturer puts his willingness to build good quality or otherwise.
Quality is an experience of the customer. Product quality perception comes from specifications of product design and the manufacturing standards achieved. Because of this reason, “Customer First” is our philosophy. We are well aware of the fact that quality in our products or service is not what we put in but what our customers take out. It is always our sincere attempt to sell not just a product, but value and experience.
Competency and Attitude
Quality starts well before the purchase of raw materials. Building good quality is a matter of choice. One may have a complete attitude to build a great quality product or service but may lack the necessary skills and competency to do so. On the other hand, one may have all the skill-sets and knowledge to build a great product or service but may not have the willingness or desire to do so. We believe it takes a balanced combination of both Competency and Attitude to create quality. Our attitude to create quality always pushes us from our comfort zones to acquire or upgrade our competencies. The vast experience and knowledge of the team members acts as bonus over existing culture.
Research and Development
With changing times, the needs of markets and customers change. Our continuous R&D activity helps us to create new products and solutions for the changing needs or to add new features in our current products by challenging conventional performance limitations. Our R&D specifications clearly define purpose of diagnostic test systems such as Accuracy levels, Sensitivity limits, Precision (within and between run), Linearity, Interferences, Uncertainty, Traceability to international standards, etc. We communicate and remain in close contact with our customers to understand their requirements. In other words, our customers play an important role to guide us for our future activities.
Most of the enzymes used by us are Genetically Engineered (GE) grade from the best sources across the globe leading to high sensitivity, specificity and performance characteristics. We employ Zwitter ionic buffers where enzymes, biochemicals and co-factors exhibit consistent and stable performance. Quality of water is of utmost importance as it is over 90% in most of the reagents. The water used for manufacturing goes through 5-step purification process to obtain highest purity and lowest contaminants. Only 25% water is recovered after such tough process which qualifies for our use. We only use AR grade (highest purity) chemicals from the most reputed manufacturers.
Our formulations have a very high conformation to international bodies likeThe International Federation of Clinical Chemistry (IFCC), German Society for Clinical Chemistry (GSCC or DGKC) and The Scandinavian Committee on Enzymes (SCE) making our products acceptable to international standards.
QA and QC protocols
Global quality is our philosophy. We have developed our internal QC specifications which not only checks the quantities of components in the reagent systems but also checks their functional performance and characteristics, which is unique to us. We also check other parameters of the reagent systems such as pH, blank of the reagent, shelf life study at different temperatures, accelerated stability study, etc. Every batch of products manufactured get tested against 4 independent third-party controls of normal as well as pathological range. Only upon satisfactory performance, the product is released into the market. In addition to this, we participate in various External Quality Assurance Services (EQAS) programs by national and international bodies.
We employ packaging materials from reputable sources through strict vendor and material specification criteria. All of our plastic and glass materials are made from virgin raw materials. Stringent 4-step washing procedure makes our materials inert and leach-proof. We also have strict leakage and breakage tests to ensure the packaging material does not compromise on our reagent quality. In few cases, we have developed customized packaging materials as per customer demands to ensure temperature stability and protection for long-distance transports.
All the products are manufactured under controlled environment such as particle-free zones, low humidity chambers and low total microbial counts. Our high-end sophisticated equipments are well maintained and well calibrated to ensure precise specifications of volumes and purity. Finished products or goods in process are stored only in virgin plastic containers having desirable specifications. Regular disinfections of manufacturing rooms and equipment are employed to ensure minimum breakdowns. We also have multiple check points or Quality-planning tools, such as the chart of operating specifications, which act as platform at various stages of manufacturing processes to ensure best product that meet all the required specifications gets passed as a final product and reduce rejections.
Our storage space spans about 700 sq. ft. in area which is has controlled environment of temperature, humidity and light. Proper classification of sub-areas helps to assign and keep the products in designated areas and their easy retrieval.
We have separate shipment partners for multiple geographical territories domestic and abroad that meet our requirements of time of deliveries, transport temperatures, etc. All our shipment partners have efficient web based tracking systems of consignments.