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About GenPep
GenPep Pharmaceuticals Pvt. Ltd.
Our purpose is “Making complex, cutting-edge healthcare solutions with cost effective processes to make accessible to all.
GenPep, meaning Generic Peptides mainly intends to set up a pharmaceutical industry with the aim of developing and manufacturing Generic Peptide APIs foe various therapeutical categories. With the vital experience in basic science along with generic peptide GenPep also focus on novel Peptide and Oligonucleotide drug molecules that can be used further for formulation and/or research purposes.
320+
Wining Awards
10k+
Test Completed
Research Excellence
Connecting Innovation & Health...
Generic Peptides
Custom Peptides & Peptide Impurities
Oligonucleotides
Quality-Pharmacopeial / Draft Guidelines
Commited - Competative Cost & Timely Delivering
Support - Developement to Commercial
Research Products
Our Core Categories
Biotech Precision
A World of Excellence in Peptides & Oligonucleotides
Research and Development
Our team at Research & Development is aimed to develop a comprehensive product portfolio of generic Peptides which are used in several chronic therapy areas such as cancer, diabetes, cardiovascular, hypertension, and Osteoporosis for the Indian as well as the regulatory market. The analytical development facility is capable to analyse the generic as well as novel peptides under one roof.
With updated cutting age technology and high ended instruments at current set up Peptides up to 40 natural and /or unnatural amino acid sequence can be synthesis, purify and qualified to use development batches for further study up to scale of 50-100 gm final output.
Our Facility
Production
The GMP production unit which is located at same premises. The GMP unit is designed in two separate streams wherein two different products can be run at a time with the aim of annual production up to 40 Kg of Peptide APIs. A team of expert from Peptide synthesis and purification is engaged to deliver the peptides at multikilogram scale with quality parameter. The facility is equipped with 20 L and 50L Solid Phase Peptide Synthesis (SPPS) reactors, Preparative HPLC (3-6L/min) with 200, 300, DAC Column, and Tray freeze dryer with 30 kg and 100 kg ice condenser capacity.
Our Facility
Quality Control
Quality Control unit at GenPep can perform the comprehensive assessment of structural integrity and purity of the peptide. We are committed to develop a robust analytical method and subsequently validation with appropriate documentations to meet the GMP compliances. Our analytical expertise can perform the key raw material and finished product analysis as per the guideline published by regulatory bodies, such as ICH (International Conference on Harmonization), FDA (Food and Drug Administration) or EMEA (European Agency for the Evaluation of Medicinal Products)
Our Facility
Regulatory Affairs
As per USFDA, peptides that are produced by synthetic or recombinant technology are regulated as drugs, and fall outside the scope of guidance written for traditional small molecule drugs as well as for biologics. Whereas as per European Pharmacopeia’s monograph Substances for Pharmaceutical Use contains reporting, identification, and qualification thresholds for impurities in synthetic peptides, but this is not globally followed and does not apply to genotoxic impurities. This makes Peptide manufacturing more challenging to determine appropriate impurity limits.
Our Facility
Driven by Science
Why Choose Us?
Deep scientific knowledge in Peptides and Oligonucleotides, enabling us to handle complex and high-value projects with precision.
- Specialized Expertise
- End-to-End Solutions
- Regulatory Excellence
- Advanced Technology
- Custom CRAMS Services
- High Quality Standards
- Cost-Effective Approach
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Permanent Staff
0k+
Test Completed
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Wining Awards
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Years Of Exps.
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Accurate Product Testing
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