What Manisha Analytical Laboratories does

Manisha Analytical Laboratories Pvt. Ltd. (MALPL) is a privately held, NABL-accredited and ISO-certified contract analytical testing laboratory founded in 1989 in Mumbai, India, by Mr. Chandubhai H. Nai, who remains Founder & Managing Director. The company provides regulated testing, analytical method development, method validation, stability studies, and R&D services to pharmaceutical formulations manufacturers, fine chemicals producers, cosmetics companies, Ayurvedic preparation manufacturers, and food-sector clients. It serves notable enterprise customers including Abbott, Dr. Reddy's, Cadila Healthcare (Zydus), Ajanta Pharma, and Ciron, among approximately 19 named enterprise accounts.

The laboratory's core technical platform comprises 21 CFR Part 11 compliant instrumentation including Shimadzu LCMS-8045 triple-quadrupole LC-MS/MS (used for nitrosamine impurity detection at ppb/ppt levels), Waters/Shimadzu/Gilent HPLC and UPLC systems, Agilent ICP-OES for elemental impurities, GC with headspace sampling, FTIR, dissolution testers, and a Malvern Mastersizer 3000 for particle size distribution. Specialized capabilities include ICH Q1A(R2) compliant stability studies across four automated walk-in chambers totaling 1,20,000 L capacity, biowaiver studies, ready-to-use nitrosamine methods covering NDMA, NDEA, NMBA, NEIPA, and NDIPA in Metformin, Sartans, Ranitidine, and Pioglitazone (50+ completed projects), and CPCSEA-compliant pyrogen and toxicity testing. Sister concern Beepharmo Labs Pvt. Ltd. extends the platform with food and agricultural accreditations (BIS, APEDA, FSSAI, AGMARK).

The business operates a sales-led, project-based B2B model with custom quote-based pricing, pay-as-you-go billing, and value-added services bundled into testing engagements. The company has grown organically from one unit to four units across Mumbai, receives inbound samples globally, and is FDA-Maharashtra licensed (valid 2022–2027), GLP-certified, and biowaiver-accredited by ISP Chile. Ownership remains concentrated with the founding family; no external PE/VC funding or public listing is identified.

Name

Manisha Analytical Laboratories

Legal name

Manisha Analytical Laboratories Pvt. Ltd.

Website

https://manishalab.com

Company type

Private

Founded year

1989

Operating status

Operating

Headcount range

101–250 employees

Short description

Manisha Analytical Laboratories is a NABL-accredited, FDA-licensed Mumbai-based contract analytical testing laboratory serving pharmaceutical, fine chemical, cosmetics, Ayurvedic, and food manufacturers with HPLC, LC-MS/MS, stability, nitrosamine, and method validation services.

Ownership category

akta.pro rank

Product category

Analytical Testing Services

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Release Testing & Batch Certification (QC) (HLAGADAC)

akta.pro secondary industries

Stability Testing (ICH Programs) (HLAGADAD), Elemental Impurities & Trace Metals (ICP-MS) (HLAGADAJ)

Keywords

• Analytical testing services
• Pharmaceutical testing laboratory
• Analytical method validation
• Nitrosamine impurity testing
• Stability studies

Headquarters

HQ city

Thane

HQ country

India

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Supply Chain

Revenue model

1. Analytical Testing Services: One-time transactional laboratory testing services for pharmaceutical formulations, fine chemicals, cosmetics, ayurvedic preparations, and food products. Services include method development, validation, stability studies, and regulatory compliance testing.
2. R&D Services: Research and development support including analytical method development using QbD approach, biowaiver studies, and nitrosamine impurity profiling. Typically project-based engagements with agreed timelines.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Manisha Analytical Laboratories is a NABL-accredited and ISO-certified contract testing laboratory providing analytical testing, analytical method development and validation, stability studies, nitrosamine impurity profiling, biowaiver studies, and regulatory-compliance testing for pharmaceutical formulations, fine chemicals, cosmetics, Ayurvedic preparations, and food products. Services are delivered through four laboratory units across Mumbai using LC-MS/MS, HPLC, UPLC, GC-HS, ICP-OES, FTIR, Malvern Mastersizer 3000, and walk-in stability chambers with 21 CFR Part 11 compliant systems.

Product overview

Manisha Analytical Laboratories Pvt. Ltd. (MALPL) is a NABL accredited and ISO certified analytical testing laboratory established in 1989, offering a comprehensive suite of testing services for pharmaceutical formulations, fine chemicals, cosmetics, and Ayurvedic preparations. The company operates multiple specialized departments including HPLC, UPLC, LC-MS/MS, GC with Headspace, ICP OES, FTIR, dissolution testing, and particle size analysis using Malvern Mastersizer technology. Their service portfolio encompasses nitrosamine impurity studies, biowaiver studies, water analysis, stability studies following ICH guidelines, analytical method development and validation, and microbiological testing. The laboratory maintains GLP compliance and FDA certification, with sister concern Beepharmo Labs holding additional accreditations from BIS, APEDA, FSSAI, AGMARK, and FDA-Maharashtra. Testing capabilities span pharmaceutical formulations, fine chemicals and raw materials, cosmetics, Ayurvedic preparations, and include elemental impurities and residual solvents analysis. The company operates from multiple locations in Mumbai with facilities equipped with 21 CFR Part 11 compliant instrumentation.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmaceutical Formulations Testing Analytical testing services for pharmaceutical formulations including assay, dissolution, and related substances testing using HPLC and other techniques. Targeted at pharmaceutical manufacturers needing regulatory-compliance data.
• Fine Chemicals & Raw Materials Testing Analytical testing services for fine chemicals and raw materials to ensure quality and compliance with regulatory standards. For chemical manufacturers and pharmaceutical raw material suppliers.
• Cosmetics Testing Analytical testing services for cosmetic products to ensure safety, quality, and regulatory compliance. For cosmetics manufacturers.
• Ayurvedic Preparations Testing Analytical testing services for Ayurvedic preparations and traditional medicinal formulations. For Ayurvedic medicine manufacturers requiring purity determination and standardization.
• Nitrosamine Impurities Studies Detection, quantification, and method development for nitrosamine impurities (NDMA, NDEA, NMBA, NEIPA, NDIPA) in pharmaceutical products including Metformin, sartan drugs, Ranitidine, and Pioglitazone using LC-MS/MS technology at ppb and ppt levels. Over 50 projects completed identifying and quantifying more than 10 different nitrosamine types.
• Biowaiver Studies Biowaiver studies to support regulatory submissions and waive bioequivalence requirements based on formulation characteristics. Accredited by ISP Chile.
• Water Analysis Comprehensive water testing services including chemical and microbiological analysis for pharmaceutical and food industry compliance, covering contamination monitoring and regulatory requirements for water used in manufacturing.
• Stability Studies Stability testing services following ICH guideline Q1A (R2) with automated walk-in chambers maintaining controlled temperature/humidity conditions (25°C±2°C/60%±5% RH, 30°C±2°C/65%±5% RH, 30°C±2°C/75%±5% RH, 40°C±2°C/75%±5% RH) and photo-stability testing per ICH Q1B. Total chamber capacity: 1,20,000 L with emergency alert system and standby chamber with generator backup.
• Elemental Impurities Testing Elemental impurity testing using Agilent ICP-OES technology for accurate, rapid, and sensitive determination of elements in pharmaceutical products, supporting ICH Q3D elemental impurity requirements.
• Analytical Method Development Development of stability-indicating methods using QbD approach for various drug substances and drug products, including assay, dissolution, residual solvents, enantiomeric purity, and related substances methods. For pharmaceutical R&D teams.
• Analytical Method Validation Method validation services based on ICH, FDA, and USP requirements with protocols and reports meeting 21 CFR Part 11 regulatory requirements for data integrity. For pharmaceutical companies preparing regulatory submissions.
• Particle Size Analysis (Malvern Mastersizer 3000) Particle size distribution analysis using Malvern Mastersizer 3000 with measurement range of 0.01 µm to 3500 µm for powders, granules, and dispersions using dry and wet methods, compliant with 21 CFR Part 11 and USP general chapter <429>.
• Microbiological Testing Comprehensive microbiological testing including method validations, microbiological assay, sterility testing, preservative efficacy, microbial limits, bioburden, bacterial endotoxin, environmental monitoring, and water analysis. For pharmaceutical manufacturers requiring sterility and microbial quality assurance.

Quantifiable outcome

• 50+ nitrosamine impurity projects completed identifying and quantifying more than 10 different types of nitrosamine impurities
• +2 more outcomes

Named customers19 records

Segments5 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Beepharmo Labs Pvt. Ltd.coreOthersSister concern and acquired laboratory that has been accredited by NABL, BIS, APEDA, FSSAI, AGMARK, FDA-Maharashtra & ISO 9001-2008. Beepharmo Labs has separate world-class Pharma & Food Labs. Operates under the same ownership and management group.

Scale indicators6 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Vimta Labs: Vimta Labs is an Indian NABL-accredited analytical testing and clinical research company offering pharmaceutical, food, and environmental testing — directly comparable to Manisha's pharmaceutical formulations QC, stability, and method validation services for Indian pharma clients.

Regional players

• Cliantha Research: Cliantha Research is an Indian CRO with bioanalytical, formulation analytical, and stability testing services; it targets similar pharmaceutical clients as Manisha but with a clinical trial-led go-to-market.
• Veeda Clinical Research: Veeda is an India-based CRO offering bioanalytical and formulation analytical services; it competes for similar pharmaceutical lab testing and method validation work in the Indian market, with a larger clinical CRO orientation.

Broad incumbents

• Intertek India: Intertek provides pharmaceutical analytical services globally including in India, overlapping with Manisha on regulatory testing, method validation, and stability studies.
• Syngene International: Syngene is a large Indian CRO/CDMO providing analytical research, method development, and stability services to global pharma — it serves the same Indian pharma analytical services market with a broader discovery-to-manufacturing offering.
• Eurofins Scientific: Eurofins is a global leader in pharmaceutical and food analytical testing with a substantial India presence; it competes for the same pharma method validation, stability, and nitrosamine work that Manisha targets, but at much greater scale.
• Piramal Pharma Solutions: Piramal Pharma Solutions is a large Indian CDMO offering analytical method development, validation, and stability services within a broader drug substance/product development offering — adjacent competitor for high-end pharma analytical work.
• Sai Life Sciences: Sai Life Sciences is an Indian CRO/CDMO with integrated analytical services including method development, validation, and stability testing serving global pharma — overlapping significantly with Manisha's regulated testing value proposition.
• SGS India: SGS operates a global testing, inspection, and certification network with pharma analytical lab services in India — overlaps with Manisha on pharmaceutical QC and stability testing, although SGS is much broader in scope.

Emerging players

• Lambda Therapeutics / Lambda CRO: Lambda is an India-based CRO providing formulation analytical and bioequivalence services; competes in the same regulated pharmaceutical testing market as Manisha, particularly for generic drug sponsors.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights14 records

Customer concentration

• LinkedInlinkedin.com/company/malpl

Compliance13 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Manisha Analytical Laboratories