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Enaltec was established in 2006 by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven products at competitive prices, thus providing the critical India advantage to generic formulators across the world. The paradigm shift of leading Indian pharmaceutical companies to target high volume and blockbuster products for regulated markets has been the inspiration behind the launch of Enaltec. Enaltec is one of the few independent Indian API suppliers with world class infrastructure, having no intention of competing with its customers in their home market. The manufacturing facility at Ambernath is WHO GMP approved and US FDA Inspected and compliant. Vision To be a partner of global healthcare industry for supplying high quality pharmaceutical products at competitive prices complying with stringent regulatory requirements. Values Customer focused and friendly – these are values that are non-negotiable for us – we live with it We believe in uncompromising integrity and insist on the highest ethical standards and transparency with our clients Ensuring speed to market – it is critical for us to continuously improve upon logistics and that keeps us on the top of our game + Read More

Nature of Business

Manufacturer

Year of Establishment

2006

Legal Status of Firm

Limited Company (Ltd./Pvt.Ltd.)

Annual Turnover

Rs. 100 - 500 Crore

GST Number

27AABCE5821H1ZS

R And D Infrastructure
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R And D Infrastructure

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Spread over an area of 10,000 sq. ft., the R & D lab is fully equipped with the latest fume hood systems with a variety of equipments ranging from lab hydrogenators to ozonisers.

  • 10 Fume hoods ??? 6 feet, with storage area for chemicals and reagents
  • 2 Walk in Hoods ??? with washing provision and Glassware storage
  • Large flasks / reactors ??? of 20, 50 and 100L assemblies
  • Rotary Evaporators ??? Heidolph and Bench top assemblies
  • Pilot hydro???generator ??? 2L

We have fully equipped Analytical lab backed with 21 CFR compliance system to meet any stringent regulatory requirements of R & D center.

Analytical lab is equipped with latest equipments like:
  • HPLCs with all types of detectors (UV / PDA / RI / Conductivity)
  • Gas chromatography with head space
  • Preparative HPLC
  • Malvern particle size analyser
  • Infrared spectrophotometer
  • Stability chambers including photo stability
  • Digital polarimeter, pH meters, Melting point apparatus
  • FTIR, Double beam UV – Visible spectrophotometer

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Technical Expertise
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Technical Expertise

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A team of 64 scientists (both in Synthesis and Analytical) working round the clock at our API R & D center.

Scientific pool and experienced team comprises of:
  • 4 PhDs with 15 to 20 years of experience
  • 20 M.Sc. With 5 to 10 years of experience

Other support staff includes IPM, Regulatory and Project Managment

Process Chemistry

Synthesis team has vast experience in handling various complex reactions ranging from hydrogenations to Suzuki couplings with ease.

The chemistry capabilities of the team, covers the following areas:
  • Chiral chemistry – chiral resolution, racemization, “enatioselective” synthesis
  • Heterocyclic synthesis (benzimidazole, indole, isoxazole, etc.)
  • Asymmetric oxidation and reduction
  • Hydrogenation, Nitration and Cynation reactions
  • Complex synthesis (selective reactions)
  • Pyrophoric Reactions
Analytical Team

Our Analytical team comprises of 30 scientist and lab assistants with experience of handling all the latest analytical equipments. We also have specialized team with vast experience in method development and validations, which supports the robustness of product specifications and compliances as per the requirement.

Intellectual Patent ManagementOur IPM team comprises of 6 members with experience in various areas as listed below:
  • Infringement Analysis
  • Patent Drafting / Prosecuting
  • Providing freedom to operate opinions
  • Identifying Para-IV opportunity
  • Providing design around strategies for branded products
  • Licensing patent applications
  • Providing business strategy
Regulatory team

Enaltec ensures adherence and compliance with all the applicable cGMP, ICH, GLP guidelines and regulatory requirements.

Key Functions
  • Act as a liaison with regulatory agencies
  • Preparation of organized and scientifically valid DMF submissions
  • Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws
  • Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans
  • Advising the companies on regulatory aspects and climate that would affect their proposed activities
  • Evaluation of products and their ROS in line with regulatory guidelines

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Crams And Cdmo
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Crams And Cdmo

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We are a Contract Development and Manufacturing Organization (CDMO), offering end-to-end services to speedup launch of a new drug to the market. We offer process development and technology transfer and manufacturing through collaborative partnership. We co-develop the end product and support the entire life cycle of a drug molecule and advanced intermediate.

Our R & D center and manufacturing site have been recognized by regulatory agencies in India and US. With strength of 80 scientists, we are focused to develop processes and achieve optimum cost for manufacturing under strict regulatory compliance.

Services Offered:
  • Process / route selection
  • Process development for pre-clinical and clinical supplies
  • Analytical method development and validation
  • Critical process parameters assessment
  • Process validation and stability studies
  • Technology transfer and manufacturing support
  • Vendor identification and development for key raw materials
Site Capabilities:
  • Pilot scale reactors ranging 500 – 2000L (stainless steel / glass-lined)
  • Hydrogenation facility
  • Kilo lab / Scale up facility 50 – 100L Glass assemblies
  • Drying, milling, micronisation and packaging facility
  • Well-equipped QC laboratories
Salient Features:
  • State of art lab services and production pilot plants
  • Manufacture of low volume “niche” APIs
  • US FDA and WHO Approved manufacturing facility
  • Onsite Quality Assurance and Regulatory Affairs support

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Regulated Market Facilities
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The Company’s own manufacturing plant is located in Ambernath, on the outskirts of Mumbai. The Plant was commissioned in 2010 and has been equipped with a focus to supply critical APIs to the highly regulated US & EU markets. The plant is WHO GMP certified and US FDA inspected twice (2013 and 2015) and has been found suitable to US FDA regulatory requirement.

This plant is spread over an area of 75,000 sq. ft., which includes Administrative Block, Production Block, Quality Control, Quality Assurance, Warehouse and Utilities.

It is best suited for manufacturing 2 products simultaneously in capacity of gms levels to few hundred kgs level (per month) for API’s and advanced intermediates.

A fully qualified HVAC system including full control of temperature, humidity and room pressure ensures the right environment for quality manufacturing. The facilities at the plant include:

  • Containment class OEB3 (up to 10 µg/m3)
  • Capabilities to handle pressurized reaction upto 50 kg/cm2
  • Capability to handle cryogenic reactions up to -70°C
  • Glass Line Reactors ??? 1,000 to 1,600L Capacities
  • Stainless Steel Reactors ??? 500L to 2,000L Capacities
  • Hydrogenator (100 L)
  • Different type of Driers (FBD, TD, RCVD and VTD)
  • Centrifuges, Neutch Filter, High Vacuum Pump, MultiMill, Jet Mill, Shifter, Blenders
  • Quality ??? HPLCs with auto sampler (UV and PDAdetectors), GC head space with auto sampler, FTIR, UV Spectrophotometer, Stability Chambers as per ICH guidelines, dedicated Microbiology Laboratory with dedicated AHU, TOC Analyzer, Auto Titrators, Digital Polarimeter with temperature controller
  • Utilities ??? HVAC System comprising of 10 AHUs, 3 FDV Ventilators, Chiller, Boiler, Compressor (oil free) and Generator, UV Water Purification System
Utilities
  • PLC controlled Purified Water System
  • HVAC System comprising of 0.3 µ terminal HEPA filters
  • Oil free, non-lubricated air compressors
  • Nitrogen distribution system for inertisation
  • Brine plant (-25°C )
  • Oil heating system (250°C )
  • Diesel Generator for back up
Warehouse
  • Well-equipped ware house with separate storage areas as per regulatory norms. Solvent are handled through dedicated underground tanks through pipeline
  • Separate storage area for intermediates and finished products stored below 25??C, 5 ±3??C and –20 ±5 ??C

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R And D Infrastructure
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R And D Infrastructure

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Enaltec’s Formulation Development Center has been set up with a clear objective of emerging as a technology leader in developing pharmaceutical products in spectrum of dosage forms which are challenging and difficult either in the product technology or the intellectual property.

Enaltec has two state of the art formulation labs based out of Ambernath which is in close proximity to Thane. Enaltec Pharma Research, is a 42,000 Sq. Ft. R & D and Enaltec Formulation Labs, is a 20,000 Sq. Ft. R & D having all the necessary equipment’s & capability to undertake product development in complex dosage forms.

Specialized Capability
  • Formulation development in spectrum of dosage forms
  • Analytical Lab compliant to GLP guidelines
  • Plans to set up Pilot GMP Manufacturing Capabilities
  • Specialized capabilities in Dermatology, Lyophilized Injectables & Potent Compounds development

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Contract Research
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Contract Research

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Enaltec has positioned itself in offering a spectrum of Contract Research and Development Services for the generic formulations across the globe through its two R & D sites viz. Enaltec Pharma Research and Enaltec Formulation Labs. The objective is to act as a adept neutral R & D partner to big pharmaceutical generic companies with a sole intention to develop and create an intellectual property for the client. All the developmental activities carried out at Enaltec are managed and conducted intelligently, scientifically and methodically to offer the best service and on time.

Enaltec has the capability to offer the full spectrum of capabilities in order to achieve speed to the market and the services include ranging from API and formulation development to the coordination of outsourced services such as bioequivalence studies and contract manufacturing, at locations where we enjoy a preferred customer status.

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Healthcare Science
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Healthcare Science

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Clinical Team
  • Identification and Qualification of CRO
  • Preparing of study monitoring and development plan
  • Monitoring of BA/BE Studies and Clinical Trials
  • Feasibility Assessment Pre-study Site Visits and Site Selection
  • Project / Contract Management
  • Clinical Trials and Site Management
  • Evaluation / Investigation of study results and Review of Module V

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Manufacturing Facilities
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Manufacturing Facilities

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Enaltec has established world class infrastructure for manufacturing APIs complying with the requirements of regulated and semi regulated markets. All the labs are GLP compliant and the manufacturing plants are cGMP approved.

Manufacturing capabilities range from gram level to multiple tonne lots. The facilities are capable of carrying out a wide range of reactions including high pressure hydrogenations and nBuLi reactions on a large scale.

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