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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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SERVICES

API Manufacturing, Analytical, API & Drug Product Development

API Manufacturing
Analytical
API & Drug Product Development
- 3 API Development
- 3 Preformulation & Material Science

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01 3API Development

02 5Analytical Method Development

03 9Analytical Testing Services

04 1Chiral Synthesis

05 2Custom Synthesis & Manufacturing

06 2Extractables and Leachables

07 1Fine Chemical / Intermediate

08 1GMP Manufacturing

09 1Hydrogenation

10 1Low Temperature / Cryogenic conditions

11 1Lyophilization

12 1Organometallic Chemistry

13 3Preformulation & Material Science

14 1Scale Up

15 2Stability Studies

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01 34Anacipher

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01 34India

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01

ANALYTICAL METHOD VALIDATION STUDIES

ANALYTICAL METHOD VALIDATION STUDIES

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ANALYTICAL METHOD VALIDATION STUDIES

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Pharma Service : Analytical

We undertake method validation studies as per ICH guidelines. This includes analytical method validation of compendial and non compendial chromatographic method. We also undertake project for analytical method development and validation for cleaning procedures.

Category : Analytical Method Development

Sub Category : Method Development and Validation

Pharma Service : Analytical

Service
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#ServicesBio

02

POLYMORPHIC SCREENING EVALUATION

POLYMORPHIC SCREENING EVALUATION

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POLYMORPHIC SCREENING EVALUATION

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Pharma Service : API & Drug Product Development

Anacipher helps in the determination of physico-chemical properties such as solubility with respect to temperature and pH, dissociation constant and partition coefficient, polymorphic screening evaluation, polymorph qualification and hygroscopicty.

Category : Preformulation & Material Science

Sub Category : Polymorph & Crystal Screening

Pharma Service : API & Drug Product Development

Service
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03

DETERMINATION OF HYGROSCOPICTY

DETERMINATION OF HYGROSCOPICTY

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DETERMINATION OF HYGROSCOPICTY

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Pharma Service : Analytical

Determination of physic-chemical properties as follows: Solubility with respect to temperature and pH, dissociation constant and partition coefficient, polymorphic evaluation and hygroscopicty.

Category : Analytical Testing Services

Sub Category : Moisture Sorption

Pharma Service : Analytical

Service
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04

DISSOCIATION CONSTANT & PARTITION CO...

DISSOCIATION CONSTANT & PARTITION COEFFI...

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DISSOCIATION CONSTANT & PARTITION CO...

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Pharma Service : Analytical

Determination of physic-chemical properties as follows: Solubility with respect to temperature and pH, dissociation constant and partition coefficient, polymorphic evaluation and hygroscopicty.

Category : Analytical Testing Services

Sub Category : pKa and LogP

Pharma Service : Analytical

Service
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Capabilities
#ServicesBio

05

LC-MS METHOD DEVELOPMENT

LC-MS METHOD DEVELOPMENT

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LC-MS METHOD DEVELOPMENT

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Pharma Service : Analytical

We undertake development of critical parameters or methods, such as analytical method to determine impurities, which don't have chromophores and hence don't have detection, Chiral method development, LC-MS suitable method development.

Category : Analytical Testing Services

Sub Category : Mass Spectrometry and LC / MS

Pharma Service : Analytical

Service
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Capabilities
#ServicesBio

06

METHOD DEVELOPMENT FOR PARTICLE SIZE...

METHOD DEVELOPMENT FOR PARTICLE SIZE ANA...

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METHOD DEVELOPMENT FOR PARTICLE SIZE...

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Pharma Service : Analytical

We undertake development of critical parameters or methods, such as method development for particle size analysis and polymorph quantification by XRD.

Category : Analytical Testing Services

Sub Category : Particle Size

Pharma Service : Analytical

Service
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07

CHIRAL METHOD DEVELOPMENT

CHIRAL METHOD DEVELOPMENT

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CHIRAL METHOD DEVELOPMENT

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Pharma Service : Analytical

We undertake development of critical parameters or methods, such as analytical method to determine impurities, which don't have chromophores and hence don't have detection, Chiral method development, LC-MS suitable method development.

Category : Analytical Method Development

Sub Category : Chiral HPLC & SFC Method Development

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

08

SCALE UP

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SCALE UP

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Pharma Service : API Manufacturing

Kilo Lab is for the production of gram to several kilogram quantities of NCE's, key intermediates and API's, Indoco Kilo Lab is a modern, state-of-the-art facility with all Equipments conforming to cGMP and GEP norms. Dedicated Multi product facility to manufacture...

Category : Scale Up

Sub Category : Overview

Pharma Service : API Manufacturing

Service
Web Link

Capabilities
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09

HIGH PRESSURE REACTION FACILITY

HIGH PRESSURE REACTION FACILITY

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HIGH PRESSURE REACTION FACILITY

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Pharma Service : API & Drug Product Development

Indoco Kilolab is a modern, state-of-the-art facility with all Equipments conforming to cGMP and GEP norms, has High pressure reaction facility and Huber System for Reactions -60°C to 200°C.

Category : API Development

Sub Category : High Pressure Reactions (> 100 psi)

Pharma Service : API & Drug Product Development

Service
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10

GMP FOR INTERMEDIATE & API

GMP FOR INTERMEDIATE & API

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GMP FOR INTERMEDIATE & API

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Pharma Service : API Manufacturing

Indoco Kilo Lab is a modern, state-of-the-art facility with all Equipments conforming to cGMP and GEP norms. Design to meet cGMP, EDQM and USFDA standards

Category : GMP Manufacturing

Sub Category : Overview

Pharma Service : API Manufacturing

Service
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11

MANUFACTURING ADVANCE INTERMEDIATE

MANUFACTURING ADVANCE INTERMEDIATE

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MANUFACTURING ADVANCE INTERMEDIATE

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Pharma Service : API Manufacturing

Indoco Kilo Lab facility is versatile to perform a wide variety of reactions and complete multi-stage intermediate and API processes. Multipurpose facility to manufacture Advance Intermediate for Rest of World markets.

Category : Fine Chemical / Intermediate

Sub Category : Overview

Pharma Service : API Manufacturing

Service
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12

MICROBIOLOGICAL TESTING

MICROBIOLOGICAL TESTING

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MICROBIOLOGICAL TESTING

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Pharma Service : Analytical

Indoco Kilolab is a modern, state-of-the-art facility with all Equipments conforming to cGMP and GEP norms. Standalone Quality Control, Instrumentation & Microbiological testing .

Category : Analytical Testing Services

Sub Category : Microbiology

Pharma Service : Analytical

Service
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Capabilities
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13

ANALYTICAL METHOD DEVELOPMENT

ANALYTICAL METHOD DEVELOPMENT

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ANALYTICAL METHOD DEVELOPMENT

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Pharma Service : Analytical

We undertake complete analytical project development activities for formulation as well as API products. This includes analytical method development for RMs, Intermediates, Inprocess and finished product in line with regulatory requirements.

Category : Analytical Method Development

Sub Category : Overview

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

14

SYNTHESIS OF KNOWN / UNKNOWN IMPURIT...

SYNTHESIS OF KNOWN / UNKNOWN IMPURITIES

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SYNTHESIS OF KNOWN / UNKNOWN IMPURIT...

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Pharma Service : API & Drug Product Development

With the help of deep organic chemistry knowledge along with state-of-the-art synthesis infrastructure, Anacipher offers synthesis services for known / unknown impurities.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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15

IMPURITIES STUDY

IMPURITIES STUDY

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IMPURITIES STUDY

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Pharma Service : Analytical

Impurities of Drug products, API and intermediates can be studied. Impurities and degradation of products can be studied and unknown impurities can be identified by means of LC-MS and LC-MS-MS analysis. Specified impurity contained within the sample can be isolated...

Category : Analytical Method Development

Sub Category : Impurity Isolation and Identification

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

16

REFERENCE STANDARDS AND IMPURITIES

REFERENCE STANDARDS AND IMPURITIES

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REFERENCE STANDARDS AND IMPURITIES

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Pharma Service : API & Drug Product Development

Reference standards / working standards of impurities & products can be qualified & characterized with a complete report for regulatory submission. Anacipher helps in in-house impurity standard generation by means of degradation & isolation or synthesis.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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17

GENOTOXIC EVALUATION

GENOTOXIC EVALUATION

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GENOTOXIC EVALUATION

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Pharma Service : Analytical

Genotoxicity of the impurity can be evaluated based on FDA approved software. It offers genotoxic and Potential extractable and leachables studies and stablishment of Specification and acceptance criteria

Category : Extractables and Leachables

Sub Category : Toxicological Risk Assessment (TRA)

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

18

EXTRACTABLE & LEACHABLES

EXTRACTABLE & LEACHABLES

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EXTRACTABLE & LEACHABLES

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Pharma Service : Analytical

Extractable and Leachables (both organic and inorganic) study in drug product. It offers development and validation of analytical methods, study stability sample for establishment of leachables maximum level, and qualification of extractable and leachables.

Category : Extractables and Leachables

Sub Category : Testing Services

Pharma Service : Analytical

Service
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Capabilities
#ServicesBio

19

DRUG EXCIPIENT COMPATIBILITY STUDIES

DRUG EXCIPIENT COMPATIBILITY STUDIES

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DRUG EXCIPIENT COMPATIBILITY STUDIES

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Pharma Service : API & Drug Product Development

The drug - excipient compatibility can be studied by subjecting the binary mixtures of drug with different excipients to the differential scanning calorimetric analysis.

Category : Preformulation & Material Science

Sub Category : Excipient Screening

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

20

STEREOCHEMICAL STABILITY

STEREOCHEMICAL STABILITY

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STEREOCHEMICAL STABILITY

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Pharma Service : Analytical

We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.

Category : Stability Studies

Sub Category : Overview

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

21

CHEMICAL & PHYSICAL STABILITY OF POL...

CHEMICAL & PHYSICAL STABILITY OF POLYMOR...

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CHEMICAL & PHYSICAL STABILITY OF POL...

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Pharma Service : Analytical

We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.

Category : Stability Studies

Sub Category : Overview

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

22

STRUCTURE ELUCIDATION BASED ON LC/MS...

STRUCTURE ELUCIDATION BASED ON LC/MS & C...

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STRUCTURE ELUCIDATION BASED ON LC/MS...

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Pharma Service : Analytical

We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.

Category : Analytical Testing Services

Sub Category : Structure Elucidation

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

23

CHROMATOGRAPHIC METHOD DEVELOPMENT &...

CHROMATOGRAPHIC METHOD DEVELOPMENT & VAL...

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CHROMATOGRAPHIC METHOD DEVELOPMENT &...

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Pharma Service : Analytical

We have extensive experience in chromatographic method development and validation including reverse phase, normal phase and Chiral HPLC methods and Head space GC methods. We have expertise in spectroscopic, titrimetric and particle size analysis methods development...

Category : Analytical Method Development

Sub Category : Method Development and Validation

Pharma Service : Analytical

Service
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#ServicesBio

24

CLEANING VALIDATION

CLEANING VALIDATION

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CLEANING VALIDATION

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Pharma Service : Analytical

We also develop and validate analytical methods for cleaning validation. Method validation will be performed using procedures according to current guidelines or customer's specification. We also offer on-site method transfers into our customer's lab by well trained...

Category : Analytical Testing Services

Sub Category : Chromatography (TLC / LC / HPLC / UPLC / GC)

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

25

POLYMORPHISM STUDIES

POLYMORPHISM STUDIES

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POLYMORPHISM STUDIES

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Pharma Service : API & Drug Product Development

Following is the list of studies that can be performed at our laboratory for polymorphism: morphology, identification of polymorph, evaluation of Polymorph for Patent, euantification of Polymorph, percentage crystallinity, equilibrium solubility of the Polymorph.

Category : Preformulation & Material Science

Sub Category : Polymorph & Crystal Screening

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
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26

LYOPHILIZATION STUDIES

LYOPHILIZATION STUDIES

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LYOPHILIZATION STUDIES

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Pharma Service : API Manufacturing

Lyophilization studies can be performed to establish isolation procedures of thermally unstable drugs, lipid, enzymes etc. We offer these services up to laboratory scales.

Category : Lyophilization

Sub Category : Overview

Pharma Service : API Manufacturing

Service
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27

TRACE ANALYSIS & CARRY OVER STUDIES

TRACE ANALYSIS & CARRY OVER STUDIES

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TRACE ANALYSIS & CARRY OVER STUDIES

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Pharma Service : Analytical

Trace analysis of impurities like organic, inorganic and residual solvents and their carry over in the finished product can be performed as per regulatory requirements. The report with suitability of the method along with the limits of detection and quantification.

Category : Analytical Testing Services

Sub Category : Trace / Elemental / Heavy Metals

Pharma Service : Analytical

Service
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Capabilities
#ServicesBio

28

RESIDUAL SOLVENTS

RESIDUAL SOLVENTS

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RESIDUAL SOLVENTS

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Pharma Service : Analytical

Trace analysis of impurities like organic, inorganic and residual solvents and their carry over in the finished product can be performed as per regulatory requirements. The report with suitability of the method along with the limits of detection and quantification.

Category : Analytical Testing Services

Sub Category : Residual Solvents

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

29

API CUSTOM SYNTHESIS

API CUSTOM SYNTHESIS

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API CUSTOM SYNTHESIS

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Pharma Service : API Manufacturing

Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

Category : Custom Synthesis & Manufacturing

Sub Category : Overview

Pharma Service : API Manufacturing

Service
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30

NON-INFRINGING SYNTHETIC ROUTES

NON-INFRINGING SYNTHETIC ROUTES

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NON-INFRINGING SYNTHETIC ROUTES

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Pharma Service : API Manufacturing

Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

Category : Custom Synthesis & Manufacturing

Sub Category : Route Scouting

Pharma Service : API Manufacturing

Service
Web Link

Capabilities
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31

CHIRAL SYNTHESIS

CHIRAL SYNTHESIS

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CHIRAL SYNTHESIS

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Pharma Service : API Manufacturing

We offer Chiral Synthesis, Chiral Separation and synthesis of chiral compounds like ACE inhibitors.

Category : Chiral Synthesis

Sub Category : Overview

Pharma Service : API Manufacturing

Service
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Capabilities
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32

CRYOGENIC REACTION FACILITIES

CRYOGENIC REACTION FACILITIES

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CRYOGENIC REACTION FACILITIES

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Pharma Service : API Manufacturing

Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

Category : Low Temperature / Cryogenic conditions

Sub Category : Overview

Pharma Service : API Manufacturing

Service
Web Link

Capabilities
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33

ORGANOMETALLIC REACTIONS

ORGANOMETALLIC REACTIONS

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ORGANOMETALLIC REACTIONS

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Pharma Service : API Manufacturing

Synthetic Labs are supported by a team of scientists for handling mg to Kg scale reactions, adequate utility services, hygienic environment, cryogenic & high pressure manufacturing facilities and separate laboratories for CRAMS and generic research.

Category : Organometallic Chemistry

Sub Category : Overview

Pharma Service : API Manufacturing

Service
Web Link

Capabilities
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34

HYDROGENATION

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HYDROGENATION

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Pharma Service : API Manufacturing

Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

Category : Hydrogenation

Sub Category : Overview

Pharma Service : API Manufacturing

Service
Web Link

Capabilities
#ServicesBio

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