Ever wondered why some pharmaceutical products achieve higher purity, safety, and consistency than others? The answer often lies in the quality of impurities used—and the suppliers behind them. Choosing the right impurity manufacturer isn’t just about compliance; it’s about gaining a real competitive edge. Finding a reliable partner can save you time, money, and countless headaches. Imagine smoother audits and stress-free R&D! Ready to discover India’s top impurity manufacturers? Let’s dive in and find your perfect match!

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API Impurities Manufacturers & Suppliers in India | Anant …

Product Details:
Anant Pharmaceuticals specializes in the production, supply, and export of API impurities, impurity reference standards, and custom research chemicals. They offer a range of impurity standards (e.g., Mertansine, Polmacoxib, Ceftriaxone EP Impurity B, Tenofovir Disoproxil USP Related Compound B, Cariprazine Cis Isomer, Buspirone EP Impurity A, Enzalutamide Impurities) with well-characterized, high-purity profiles. The company also provides analytical services, custom chemical synthesis, and technical support for the pharmaceuticals sector.

Technical Parameters:
– API impurities conform to regulatory norms using advanced purification
– Manufacturing facilities are FDA (Maharashtra) approved, ACCAB ISO IEC 17025
– Products include unique reference standards with available catalog and CAS
– Experienced professionals handle raw materials, manufacturing, regulatory

Application Scenarios:
– Testing, analysis, and validation of pharmaceutical formulations for impurity
– Research and development in pharmaceutical companies requiring reference
– Custom synthesis projects for pharmaceutical and chemical industries
– Solving complex pharmaceutical impurity identification and synthesis challenges

Pros:
– Compliant with international quality and regulatory standards (ISO 9001:2015,
– Wide range of high-purity, well-characterized impurity reference standards in
– Offers custom research, analytical, and technical support tailored to client
– Strong reputation for reliability, competitive pricing, and personalized

Cons:
– Specific technical data (purity, storage conditions, grades, etc.) for each
– Some information on scope/limits of services and response times is not clearly

OLYMPUS Impurities Standard Suppliers | Impurity Supplier in India …

Hemarsh Technologies | Impurities Manufacturer and Suppliers in India

Product Details:
Hemarsh Technologies specializes in the contract research and synthesis of pharmaceutical impurities, providing well-characterized reference standards and services such as degradation, isolation of impurities, and metabolite synthesis. Key featured products include impurities and reference compounds for drugs such as Lisinopril, Orlistat, Saxagliptin, Tigecycline, Atorvastatin, Azacitidine, Desloratadine, Doxycycline, and Ethinylestradiol.

Technical Parameters:
– Products are reference standards and impurities used for analytical method
– Offerings include custom synthesis, impurity profiling, metabolite synthesis,
– All products and services are targeted at pharmaceutical R&D and quality

Application Scenarios:
– Pharmaceutical research and development
– Quality control and validation of analytical methods
– Regulatory submissions and ensuring compliance with pharmacopeial standards
– Isolation and identification of drug impurities during formulation and

Pros:
– Well-characterized reference standards for high accuracy in pharmaceutical
– Wide international market reach, supplying to multiple global regions
– Comprehensive offering that covers synthesis, profiling, and process development
– Expertise in custom and contract research for pharmaceutical impurities

Cons:
– Highly specialized offerings mainly suitable for pharmaceutical industry clients
– Limited focus outside impurities/reference standards (may not offer other types

GLP Pharma Standards

Product Details:
GLP Pharma Standards offers high-quality API impurities, Nitroso impurities, drug working standards, reference standards, catalysts, peptides, drug metabolites, stable isotope labelled compounds, fine chemicals, agro chemicals, and custom synthesized molecules. The company is based in Hyderabad, India and supplies these products globally with free shipping for the UK, US, and Europe. Products are available in custom pack sizes and are manufactured under strict quality controls.

Technical Parameters:
– API impurities, Nitroso impurities, drug working standards, reference standards
– Products meet high standards of purity and accuracy with strict quality control
– Custom pack sizes available
– Recent products include specific impurities such as Montelukast EP Impurity E

Application Scenarios:
– Pharmaceutical research and development
– Quality control and regulatory compliance in drug manufacturing
– Reference standards for analytical testing
– Identification, isolation, and characterization of unknown impurities in

Pros:
– High purity and quality with strict manufacturing standards
– Wide range of pharmaceutical standards and custom synthesized molecules
– Customizable pack sizes and competitive pricing for global customers
– Free shipping offered on UK, US, and European orders

Cons:
– Company is based in India, which may involve longer shipping times for some
– No specific information on batch-to-batch reproducibility or technical

Impurities Manufacturer and Supplier – Daicel Pharma Standards

Product Details:
Daicel Pharma Standards manufactures and supplies high-quality pharmaceutical impurities, reference standards, peptide standards, isotope labelled standards (2H, 13C), APIs, metabolites, and glucuronides. Offerings are available in quantities from milligram to multigram scale and include custom synthesis of complex impurities and peptides.

Technical Parameters:
– Stable isotope labeling with 2H and 13C for APIs and standards
– Product quantities available from milligram to multi gram scale
– Custom synthesis capabilities for target impurities, metabolites, and peptide
– Preparative purification and multi-step synthesis approaches for complex

Application Scenarios:
– Pharmaceutical research and drug development requiring impurity reference
– Analytical method development, validation, and transfer support
– Quality control and regulatory compliance in pharmaceutical manufacturing
– Customization for unique or complex peptide and metabolite standards in R&D

Pros:
– Wide range of high-quality pharma standards, including stable isotope labelled
– Custom synthesis for both known and complex unknown impurities, including
– Expertise in advanced multi-step synthesis and preparative purification
– Supports improved cost efficiency and safety for timely drug development

Cons:
– No explicit mention of certification, regulatory accreditations, or quality
– Specific limitations on turnaround time, pricing, or minimum order quantities

Complex Impurities Suppliers in India | Simson Pharma Limited

Product Details:
Simson Pharma offers a wide range of pharmaceutical reference standards, impurities, metabolites, working standards, APIs, and stable isotope labelled compounds. They also provide custom synthesis, contract research, and analytical services for pharmaceutical and research organizations.

Technical Parameters:
– Products meet international quality standards and regulatory requirements.
– Availability of characterization data, CoA (Certificate of Analysis), and MSDS
– Products supplied in various quantities based on customer requirements.
– Ability to synthesize custom molecules to specified purity and quality.

Application Scenarios:
– Pharmaceutical research and development.
– Analytical method development and validation.
– Quality control in drug manufacturing.
– Regulatory submission and compliance testing.

Pros:
– Extensive catalog of pharmaceutical reference materials and impurities.
– Custom synthesis and analytical service offerings to meet client-specific needs.
– Strict quality control procedures and comprehensive documentation provided.
– Global supply capabilities with timely delivery.

Cons:
– Detailed pricing information is not readily available on the website.
– Specific product technical datasheets or detailed specifications for every
– Dependence on direct inquiry for availability or ordering process.

Impurity Standard Suppliers And Manufacturers in India – Simson Pharma

Product Details:
Simson Pharma offers a comprehensive catalog of high-quality impurity standards for pharmaceutical companies, including those listed in major pharmacopeias (USP, EP, BP). These impurity standards are synthetic or metabolite compounds supplied with full analytical data, produced to enable precise identification and quantification in drug development and manufacturing.

Technical Parameters:
– High purity and well-characterized impurity standards suitable for related
– Impurity standards include synthetic impurities and known metabolites,
– Comply with major pharmacopeial standards (USP, EP, BP) for impurity
– Reliable supply chain ensuring consistent availability to customers.

Application Scenarios:
– Development and manufacturing of pharmaceuticals in compliance with regulatory
– Identification, quantification, and control of impurities in active
– Validation of analytical methods for impurity detection.
– Support for laboratory studies and batch testing during drug development,

Pros:
– Comprehensive range and high quality of impurity standards available for
– Technical support and expertise provided by qualified scientists for effective
– Competitive pricing and cost-effectiveness due to efficient operations.
– Enhances the quality and regulatory compliance of pharmaceutical products made

Cons:
– No detailed product-specific technical specifications or purity data provided
– Information on potential limitations or exclusions (e.g., impurities not

Pharmaceutical Research Reference Standards Manufacturer and Supplier …

Product Details:
AquigenBio specializes in manufacturing and supplying pharmaceutical research reference standards in India, with products including API & intermediates, impurity standards (such as Cyclic-His-Liraglutide Impurity, D-Allo-Thr(11)-Liraglutide Impurity, and D-Allo-Thr(13)-Liraglutide Impurity), peptide impurity standards, nitrosamine standards, and deuterated labelled compounds.

Technical Parameters:
– Reference standards designed for pharmaceutical research applications
– Availability of specific impurity standards for APIs including peptide
– Capability to supply deuterated labelled compounds
– Offerings include both small molecule (APIs, intermediates) and peptide-based

Application Scenarios:
– Pharmaceutical research and drug development
– Quality control and impurity profiling in pharmaceutical manufacturing
– Analytical method development and validation
– Regulatory submissions and compliance testing for pharmaceuticals

Pros:
– Comprehensive range of impurity reference standards for diverse APIs
– Special focus on peptide impurities and complex molecules
– Capability to supply specialized and hard-to-source impurities
– Targeted services such as API impurity synthesis, medicinal chemistry, and

Cons:
– Limited publicly available technical specifications or certificates of analysis
– No pricing or lead time information provided directly
– Detailed product documentation appears accessible only upon direct inquiry or

Pharma Impurities | Dr. Ashavin | Impurities Standard Suppliers …

Product Details:
Dr. Ashavin’s Lab specializes in supplying over 4000 pharmaceutical impurity standards, process intermediates, and fine chemicals, supporting pharmaceutical quality control, process optimization, and regulatory compliance. The company provides contract research and manufacturing services (CRAMS), technology development for API process development, and intellectual property rights consulting.

Technical Parameters:
– Over 4000 specialized chemical products, including API impurities, process
– Focus on high-purity, structurally complex molecules suitable for drug
– Expertise in robust, transferable, and scalable process development for APIs.
– Contract research and manufacturing services (CRAMS) with diverse route

Application Scenarios:
– Pharmaceutical quality control and regulatory risk assessment.
– API process development and process optimization.
– Research, drug development, and medical/biochemical innovation.
– Commercial-scale production for pharmaceutical and specialty chemical

Pros:
– Extensive product inventory with 4000+ unique and specialized chemical
– Proven expertise with over 35 years of industrial experience.
– Client-focused approach with a track record of serving 200+ clients globally.
– Comprehensive service offerings covering synthesis, process development, and

Cons:
– Detailed technical specifications for individual products are not specified on
– Pricing details, regulatory certifications, and shipping information are not
– Limited public information about product validation or third-party

Mole Labs Impurities manufacturer and Suppliers In Hyderabad

Product Details:
Mole Labs is a Hyderabad-based manufacturer and supplier specializing in API impurities, API intermediates, fine chemicals, carbohydrates, prostaglandins, and vitamin chemistry. Key product lines include building blocks, boronic acids, imidazoles, indoles and oxindoles, anilines, and nitrobenzenes. The company serves global pharmaceutical clients and operates as an independent contract research organization.

Technical Parameters:
– Product portfolio includes API impurities, API intermediates, fine chemicals,
– Expertise in synthesis of boronic acids, imidazoles, indoles, oxindoles,
– Focus on manufacturing building blocks and carbohydrate compounds.
– Project management system supported by an established infrastructure.

Application Scenarios:
– Quality control and impurity profiling in pharmaceutical manufacturing.
– Research and development for drug discovery and synthesis.
– Production of pharmaceutical active ingredients and intermediates.
– Sourcing fine chemicals and specialty biomolecules for custom research projects.

Pros:
– Offers a broad range of specialized chemicals suited for pharma R&D and
– Run by experienced managers and R&D scientists with a global client base.
– Emphasis on quality, innovation, and reliability.
– Solid infrastructure supporting project execution.

Cons:
– Limited publicly available details on specific technical certifications or
– Website contains some navigation and content inconsistencies (e.g., spelling

Comparison Table

Company	Product Details	Pros	Cons	Website
API Impurities Manufacturers & Suppliers in India	Anant …	Anant Pharmaceuticals specializes in the production, supply, and export of API	Compliant with international quality and regulatory standards (ISO 9001:2015,	Specific technical data (purity, storage conditions, grades, etc.) for each
OLYMPUS Impurities Standard Suppliers	Impurity Supplier in India …
Hemarsh Technologies	Impurities Manufacturer and Suppliers in India	Hemarsh Technologies specializes in the contract research and synthesis of	Well-characterized reference standards for high accuracy in pharmaceutical	Highly specialized offerings mainly suitable for pharmaceutical industry
GLP Pharma Standards	GLP Pharma Standards offers high-quality API impurities, Nitroso impurities,	High purity and quality with strict manufacturing standards Wide range of	Company is based in India, which may involve longer shipping times for some	glppharmastandards.com
Impurities Manufacturer and Supplier – Daicel Pharma Standards	Daicel Pharma Standards manufactures and supplies high-quality pharmaceutical	Wide range of high-quality pharma standards, including stable isotope labelled	No explicit mention of certification, regulatory accreditations, or quality	www.daicelpharmastandards.com
Complex Impurities Suppliers in India	Simson Pharma Limited	Simson Pharma offers a wide range of pharmaceutical reference standards,	Extensive catalog of pharmaceutical reference materials and impurities. Custom	Detailed pricing information is not readily available on the website. Specific
Impurity Standard Suppliers And Manufacturers in India – Simson Pharma	Simson Pharma offers a comprehensive catalog of high-quality impurity standards	Comprehensive range and high quality of impurity standards available for	No detailed product-specific technical specifications or purity data provided	www.simsonpharma.com
Pharmaceutical Research Reference Standards Manufacturer and Supplier …	AquigenBio specializes in manufacturing and supplying pharmaceutical research	Comprehensive range of impurity reference standards for diverse APIs Special	Limited publicly available technical specifications or certificates of analysis	aquigenbio.com
Pharma Impurities	Dr. Ashavin	Impurities Standard Suppliers …	Dr. Ashavin’s Lab specializes in supplying over 4000 pharmaceutical impurity	Extensive product inventory with 4000+ unique and specialized chemical
Mole Labs Impurities manufacturer and Suppliers In Hyderabad	Mole Labs is a Hyderabad-based manufacturer and supplier specializing in API	Offers a broad range of specialized chemicals suited for pharma R&D and	Limited publicly available details on specific technical certifications or	molelabs.in

Frequently Asked Questions (FAQs)

How can I verify the credibility of an impurity manufacturer in India?
Start by checking if the manufacturer is certified (ISO, GMP), has necessary licenses, and a good track record. Look for client testimonials, industry awards, and ask for references. Third-party audits and site visits can provide added assurance.

What key factors should I consider when choosing an impurity supplier?
Focus on product quality, consistency, regulatory compliance, customization options, delivery timelines, and after-sales support. Compare pricing but prioritize reliability and quality to avoid downstream issues.

How do I assess the quality and purity of impurities provided by a manufacturer?
Request detailed Certificates of Analysis (CoAs), method of synthesis, and characterization data (NMR, HPLC, LC-MS). Reputable suppliers typically provide samples for independent lab verification upon request.

Are Indian impurity manufacturers compliant with international regulations?
Many leading Indian manufacturers follow international standards (ICH, USFDA, EU guidelines), but always confirm their compliance. Ask for documentation regarding relevant certifications and past regulatory audits.

What is the typical lead time for production and delivery?
Lead times vary depending on complexity and quantity, but most impurity suppliers need 2–6 weeks. Custom synthesis may take longer. Always clarify timelines before placing an order and ensure their logistics can meet your deadlines.