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First Time US Pharmaceuticals India

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Navi Mumbai, IN

About First Time US Pharmaceuticals India

First Time US Pharmaceuticals (India) Pvt. Ltd. is an independent testing laboratory providing personalized product development and analytical services to the pharmaceutical and chemical industries. We specialize in Product Development, Analytical Research and Development Testing Services, Quality Control... Show more »

First Time US Pharmaceuticals (India) Pvt. Ltd. is an independent testing laboratory providing personalized product development and analytical services to the pharmaceutical and chemical industries. We specialize in Product Development, Analytical Research and Development Testing Services, Quality Control Testing and Stability Storage & Testing Services.

Our goal is to provide high quality, cost effective and timely service, personalized to meet your needs.

First Time US Pharmaceuticals India Pvt. Ltd. has 5000 sq. ft. facility at its Navi Mumbai site dedicated for product development and testing services.

We have combination of state-of-the art analytical instrumentation, manufacturing equipment and, infrastructure meeting global development standards.

Our technology development team consists of scientists drawn from some of the best research universities and organizations around the world.

We offer a highly qualified laboratory team with extensive pharmaceutical experience and excellent knowledge of FDA/cGMP requirements. Our program managers and chemists bring years of laboratory experience with unique entrepreneurial perspective. We have a knowledgeable team that understands all aspects of manufacturing, product development, quality assurance and regulatory compliance.

Our dedicated team of employees are experienced in developing and testing a variety of products and dosage forms including but not limited to oral formulations like, liquid, suspension, powder, pellets, capsule, tablets, immediate, delayed, controlled or sustained-release. We take pride in our ICH-compliant stability management program for stability testing.

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Diversity Certificates

Small business

Our Services (19)


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ICH Stability Testing

Price on request
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eCTD Services

Price on request
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FDA Audit Support

Price on request
  • Pre Approval Inspection Services
  • FDA Deficiency Response Preparation
  • SOP preparation and review Services
  • Laboratory Auditing
  • Vendor Audit and Qualification
  • Training
  • Product recall
  • Deviation, Investigation and CAPA
  • Co-ordination of response and activities with US-FDA after inspection
  • Pre Approval Inspection Services
  • FDA Deficiency Response Preparation
  • SOP preparation and review Services
  • Laboratory Auditing
  • Vendor Audit and Qualification
  • Training
  • Product recall
  • Deviation, Investigation and CAPA
  • Co-ordination of response and activities with US-FDA after inspection
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Regulatory Affairs Consulting

Price on request

We provide regulatory services including but not limited to:

  • Establishment registration in SPL format
  • Labeller code request SPL format
  • Drug listing in SPLR4 format
  • NDC number assignment for your products
  • Assistance in establishing FDA gateway
  • Self identification
  • Assistance in creating GDUFA facility 3974... Show more »

We provide regulatory services including but not limited to:

  • Establishment registration in SPL format
  • Labeller code request SPL format
  • Drug listing in SPLR4 format
  • NDC number assignment for your products
  • Assistance in establishing FDA gateway
  • Self identification
  • Assistance in creating GDUFA facility 3974 form
  • Preparation of XML backbone for eCTD
  • eCTD validation
  • Amendment for ANDAs in eCTD till approval
  • Preparation and submission of deficiency response to FDA enquiry, Adverse Event Report, Annual report
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Pharmaceutical Formulation

Price on request

We also offers complete product development package including product development report based on Quality by Design. The services can also be extended to completion of successful of human biostudies for submission. We specialize in developing product such as immediate, sustained, delayed, controlled release tablet or capsule and... Show more »

We also offers complete product development package including product development report based on Quality by Design. The services can also be extended to completion of successful of human biostudies for submission. We specialize in developing product such as immediate, sustained, delayed, controlled release tablet or capsule and oral liquid.

Our modern product development equipment include

  • Tablet press
  • Fluid Bed Processor
  • Tablet coater
  • Hot Melt Extruder
  • Jacketed High Shear Granulator
  • Encapsulator
  • Blenders

Various testing equipment such as hardness tester, friabilator, disintegrator, dissolution tester, moisture analyser.

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Product Stability Testing

Price on request
  • In-House Stability Storage Services according to ICH Guidelines
  • Specialized Storage Services according to client specified conditions
  • Stability Testing Services
  • Stability Protocol and Report Preparation
  • Stability Data Analysis and Specification Proposal
  • Retain Sample Storage Services
  • Annual Inspection of Retains
  • In-House Stability Storage Services according to ICH Guidelines
  • Specialized Storage Services according to client specified conditions
  • Stability Testing Services
  • Stability Protocol and Report Preparation
  • Stability Data Analysis and Specification Proposal
  • Retain Sample Storage Services
  • Annual Inspection of Retains
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Drug Formulation Evaluation

Price on request
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Drug Preformulation

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Impurity Analysis

Price on request
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Analytical Method Development

Price on request

We offer stability indicating analytical method development, verification and validation services in compliance with FDA and ICH guidelines. Method development and validation can be performed based on in-house or client supplied protocols.

The method development and validation services include providing test methods and... Show more »

We offer stability indicating analytical method development, verification and validation services in compliance with FDA and ICH guidelines. Method development and validation can be performed based on in-house or client supplied protocols.

The method development and validation services include providing test methods and validation reports drafted to in-house requirements or client specifications.

  • Analytical Methods Development
  • Method Feasibility/Pre Validation Studies
  • Analytical Method Validation
  • Analytical Method Transfer
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Chemistry and Materials

Price on request
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Product Development, Testing, and Packaging

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Assay Development

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Project Management

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Process Consulting

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Product Testing Services

Price on request

Product Testing Services

Product Testing Services

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Formulation Services

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Analytical Chemistry Services

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Regulatory Affairs Services

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Hrushikesh Patil

Head Business Process

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