Business Portfolio

By Business Development Team Stabicon Life Sciences FY 2019-2020 Stabicon Business Portfolio www.stabicon.com Life

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Index

Sr. Business Segment Services Portfolio Page No No 1 Formulation Development – Dosage 2 -3 2 Brand Extension Form 4-4 3 Biowavier - In-vitro Program 5-7 4 Delivery Enhancement Technology 8-8 5 Formulation Reverse Engineering 9-10 6 Antimicrobial Screening & Dosage Development Program 11-12 7 Laboratory & Stability Program 13-19 8 Turnkey & Training 20-20 9 Referral Lab 21-22

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1. Formulation Development –

Sr. No system Type Dosage form Pill Oral Delivery through Digestive 1 Solids Lozenges & tract(enteral) Buccal & sub lingual Tablets Osmotic delivery system (OROS) Granules, Spray Drops Ointment Hydrogel Solid/Semi- 2 Ophthalmic /Otologic / Nasal solid/ Mucoadhesive micro disc (microsphere tablet) Ointment

Pessary (vaginal ) Extra-amniotic infusion Solid/Semi- 3 Urogenital Tablets solid/Liquid Intravesical infusion Ointment Suppository Solid/ Semi- 4 Rectal (enteral) Hydrogel solid/Liquid Murphy drip Nutrient enema Ointment Topical Solid/ Semi- 5 Dermal solid/Liquid Film

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Film DMSO drug solution Hydrogel 5 Dermal Transfer some vesicles Medicated Dusting Powder

Suspensions

Emulsions 6 Parenteral Dry filled into vials (to be reconstituted)

Lyophilized dosage forms

Preservative free

3

Confidential Document Email:[email protected]

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2. Brand Extension Form

Brand extension or brand stretching is a marketing strategy in which a firm marketing a prod uct with a well-developed image uses the (same) brand name in a different product category. Our Offering in more than one product category:

 Extension to related categories.  Extension to unrelated categories.

We Build strategy of brand extension on following categories:

 Expanding the core promise to the new users.  Blocking or inhibiting competition.  Managing a dynamic environment

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3. Biowavier - In-vitro Program

Section-3a: Invitro Studies for Nonsystematic Drugs

Sr. No Molecule Route Applications / Oral Anti-cholesterol (Bile acid 1 Cholestyramine (Light/Regular) Sequestrate Tablet/Suspension: oral Anti-cholesterol (Bile acid 2 Colesevelam hydrochloride Sequestrate

Granule; Oral Anti-cholesterol (Bile acid 3 Colestipol hydrochloride Sequestrate 4 Sevelamer hydrochloride Suspension; Oral Renal (Phosphate Binding)

5 Sevelamer Carbonate Tablet/Suspension; Oral Renal (Phosphate Binding) Chewable Renal (Phosphate Binding) 6 Lanthanum Carbonate Tablets/Oral/Suspension & Kinetics

7 Calcium Acetate Tablets/Oral Renal (Phosphate Binding) Powder; oral/rectal Renal (K+ Binding)

8 Sodium polystyrene sulfonate Powder; oral/rectal Renal (K+ Binding) 9 Calcium polystyrene sulfonate Tablet/Suspension: oral Renal (K+ Binding) 10 Sucroferric Oxyhydroxide Granule; Oral Renal (K+ Binding) 11 Ferric Citrate Suspension/ Oral Duodenal ulcer(Bile acid 12 Sucralfate and protein binding & pepsin inhibition)

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Section -3b: Nasogastric and Gastronomy (NG) Tube Invitro Studies

Sr. No Molecules Route Applications Delayed Release 1 Lansoprazole DR Capsule Proton pump inhibitor Capsule/Oral Esomeprazole Strontium DR Capsule, Delayed Release; 2 Proton pump inhibitor Capsule Oral Esomeprazole magnesium DR Capsule, Delayed Release 3 Proton pump inhibitor Capsule Pellets; Oral Extended Release Capsule;

4 Morphine Sulfate Pain management Oral

5 Rivaroxaban Tablet; Oral Anticoagulant

Section-3c: Topical/ Invitro Release Testing (IVRT)

Invitro release of API from topical and transdermal products, and subsequent permeation through a membrane, can be tested in a vertical diffusion cell (i.e. Franz diffusion cell). In this apparatus, formulation is applied or put in contact with a membrane that is in contact with a receiving medium. The receiving medium is sampled as a function of time and API is quantities to determine a permeation/flux profile. Membrane materials include synthetic polymer, tissue constructs. The choice of membrane is driven by the purpose of the test (i.e. development vs. quality control) and robustness of the model. This technique is applicable not only to externally applied topical formulations, but also to products that deliver via the vaginal, rectal, buccal, or nasal routes.

Section-3d: Microbial Invitro Evaluation:

Invitro microbial kill rate study as per USFDA guidance Invitro Evaluation of the Antimicrobial properties for various application

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Section-3e: Bio-wavier for Solid Orals:

A Bio-waiver of solid oral means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent. This kind of study only can be done with specific classification (BCS) class 1 & 3. To understand BCS (BIOPHARAMCEUTICAL CLASSIFICATION SYSTEM) is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability

Class I - high permeability, high solubility

Example: Metoprolol- Those compounds are well absorbed and their absorption rate is usually higher than excretion.

Class III - Low permeability, high solubility

Example: Cimetidine -The absorption is limited by the permeation rate but the drug is solvated very fast. If the formulation does not change the permeability or gastro-intestinal duration time, then class I criteria can be applied. Reference : https://www.fda.gov/downloads/Drugs/Guidances/ucm070246.pdf

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4. Delivery Enhancement Technology

Drug delivery plays a vital role in bringing a drug’s therapeutic value to patients. Our delivery technologies enhance drug absorption, efficacy, and patient experience. We can improve taste masking increase the commercial viability of your pharmaceutical products by neutralizing the strong, bitter tastes of certain oral medical formulations. Our expert can increase bioavailability of medications within the system by following approaches :-

 To enhance drug solubility

 The surfactant properties of self-emulsifying and self-micro-emulsifying drug delivery systems (SEDDS and SMEDDS) can be used to improve the dispersion and solubilisation of drugs in the .

 The digestion of lipid excipients (oils and surfactants) in combination with the drug product can improve solubilisation and absorption in the gastrointestinal tract.  To enhance drug absorption, lipid excipients can be used

 To act upon the enterocyte-based transport mechanisms, for example by inhibiting the P-glycoprotein efflux transporter that controls drug uptake and efflux.

 To facilitate uptake by the lymphatic transport system, thereby eliminating first-pass metabolism in the liver and improving bioavailability.

 To inhibit pre-systemic enzyme activity, notably from the P450 enzymes, that can increase the cellular concentration of the drug.

 Our controlled release technology, offer a solution for pharmaceutical actives that require controlled release, abuse deterrent properties and environmentally stimulated release. Tailored to your needs, our technology is capable of loading even difficult to load actives.

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5. Formulation Reverse Engineering

Application for generic approval or potential therapeutic molecule under regulatory bodies requires the demonstration of a bioequivalent product or proof of concept for approval. This means that the blood levels of the active ingredient need to show that the product is highly similar in innovator composition in case of generic and therapeutic activity better than existing therapy line. Innovator’s formula as it is proprietary, contents are not revealed by the agency.

Stabicon team has handled of reverse engineering services for Q1 (Qualitative) and Q2 (Quantitative) equivalency of topical\oral products for IVRT\ Equivalence efficacy studies (Q3)

based on Regulatory Guidance & BCS classification system. Expertise is summarized in the table below:

Sr. No. Route Q1 (Qualitative) Q2 (Quantitative) Q3 (Delivery Action )

1 Topical & Transdermal feasible feasible feasible 2 Oral Dosage forms feasible feasible feasible

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Figure: Example Representation of reverse engineering approach for Product Formulation.

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6. Antimicrobial Screening & Dosage Development Program

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Potential Source - AMR

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7. Laboratory & Stability Program

Program Offered

1. Centralized stability center for global market 2. Centralized analytical & Microbiology support for MD & MV 3. Third party product certification

Section-7a: Physical Analysis Capabilities

Sr. No Test Parameter 1 Uniformity of Weight / Weight Variation 2 Uniformity of Dosage Units (by weight) 3 Uniformity of Dispersion 4 Diameter / Thickness / Length / Width (For each ) 5 Hardness 6 Disintegration test 7 Friability test 8 Loss on Drying / LOD 9 Dispersion 10 Bulk density 11 Jelly strength 12 Particle size(Microscopic) 13 Specific surface area 14 Bloom strength 15 Crystallinity 16 Particulate matter 17 Redispersability 18 Deliverable volume 19 Content of packed dosage form 20 Wetting time 21 Volume in container 22 Tapped density (Manual) 23 Sieve analysis per sieve /30 mesh size,20 mesh size

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Section-7b: Chemical Analysis Capabilities

Sr. No Evaluation parameter 1 Loss on Ignition / sup hated Ash 2 Heavy metals 3 Arsenic 4 Melting point / melting range 5 Acidity / alkalinity 6 Total hardness 7 Total dissolved solids 8 Color / Clarity of Solution (Chemical) 9 Chlorides, by Titration 10 Chlorides (qualitative test) 11 Sulphates/Sulphites , by Titration / Gravimetry 12 Sulphates/sulphites (qualitative test) 13 Solubility in water 14 Solubility in solvents (each) 15 Density /Specific gravity (weight per ml) 16 Identification by Chemical 17 Distilling range 18 Assay by chemical 19 Residue on evaporation 20 Assay by aqueous titration 21 Assay by Non Aqueous Titration 22 Uniformity of Content by Chemical 23 Iodine value 24 Saponification value 25 Acid value 26 Peroxide value 27 Volatile oil content 28 Cyanide content 29 Potassium content 30 Sodium content 31 Freezing point 32 Nitrogen determination-Kjeldhal method 33 Reducing sugars (Reducing sugars before hydrolysis) (Based on Method) 34 Aldehydes and reducing substances (Based on Method) 35 Reducing sugars after hydrolysis (Based on Method) 36 Esters Business Development Email:[email protected] 14 Stabicon Business Portfolio www.stabicon.com Life

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37 Lead 38 Nickel 39 Congealing temperature 40 Sucrose analysis by Titration (Based on Method) 41 Calcium and Magnesium 42 Fluoride (Based on Method) 43 Ammonium 44 Reducing impurities 45 Dextrin

Section-7c: Instrumental Analysis Capabilities

Sr. No Evaluation parameter 1 Identification by HPLC -UV detector 2 Identification by HPLC -RI detector 3 Identification by GC-FID detector 4 Amino acid analysis by HPLC-UV detector 5 Identification by IR 6 Identification by TLC 7 Identification by UV 8 Optical Rotation by Digital Polari meter (Specific optical rotation) 9 Assay by HPLC -UV detector /UPLC-PDA 10 Assay by HPLC -RI detector 11 Assay by GC-FID detector with head space 12 Assay by GC-FID detector without head space 13 Assay by UV 14 Assay by TLC 15 Dissolution by HPLC /UPLC-PDA 16 Dissolution by UV / Chemical, for Single Time Point 17 Preservative content by UPLC 18 Preservative content by HPLC-UV detector//UPLC-PDA 19 Preservative content by HPLC-RI detector 20 Uniformity of content by UPLC 21 Uniformity of Content by HPLC-UV detector 22 Uniformity of Content by HPLC-RI detector 23 Uniformity of Content by UV / Chemical 24 Related substances / Compounds by HPLC UV detector /UPLC-PDA 25 Related substances / Compounds by HPLC RI detector /UPLC-PDA 26 RS by GC FID Detector with head space

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27 RS by GC FID Detector without head space 28 Organic Volatile Impurities (Up to four) by GC-FID detector 29 Potentiometric titration 30 Related substances/TLC 31 Forced Degradation Study as per ICH (5 degradation Pathways)

Section-7d: Microbiological Analysis Capabilities

Sr. No Evaluation parameter 1 Preservative Efficacy Testing (Five Microorganisms with five intervals) 2 MLT Validation (Per Microorganism) 3 MLT Verification(Per Microorganism) 4 BET 5 Environmental Monitoring Analysis 6 BET Validation & Verification 7 Organism Identification (Gram staining -per colony) 8 Organism Identification (Lacto phenol cotton blue staining -per colony) 9 Organism Identification (Acid fast staining-per colony) 10 Water analysis(Raw water, Untreated process water, Treated Process water) 11 Preservative Efficacy Testing ,Validation, Verification, Assay, Dissolution Study

Section-7d.1: Bioburden Analysis Capabilities

Sr. No Evaluation parameter 1 Bioburden test 2 Bioburden validation

Section-7d.2: Microbial Limit Analysis Capabilities

Sr. No Evaluation parameter 1 Microbial limit test 2 Microbial limit test validation & verification

Section-7d.3: Sterility Analysis Capabilities

Sr. No Evaluation parameter 1 Sterility test 2 Sterility test validation & verification

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Section-7d.4: Antimicrobial Activity Studies

Sr. No Evaluation parameter 1 Kirby Bauer Disc method 2 Minimum inhibitory concentration 3 Agar plug diffusion method 4 Agar well diffusion method 5 Cross streak method 6 Agar diffusion 7 Dilutions methods 8 Time kill rate study

Section-7d.5: Others

Sr. No Evaluation parameter 2 Disinfectant Qualification test 3 Disinfectant efficacy studies 4 Environmental Monitoring 5 Water analysis 6 Enzyme Activity study (Invitro) 7 Bacterial Endotoxin test 10 Bacteriostatic/Fungi stasis Study of the pepsin Enzymatic activity in Invitro dissolution test by UV/VIS 11 Spectrophotometry

Section-7e: Comparative Dissolution Profiles

Sr. No Evaluation parameter 1 Development of discriminating dissolution Method by HPLC/UPLC 2 Development of Discriminating Dissolution Method by UV 3 CDP (Test & Reference), 4 Time Points up to 4 media, BY HPLC 4 CDP (Test & Reference), 4 Time Points up to four media, BY UV

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Section-7f: Method Development

S.N Evaluation parameter 1 Method Development for Assay / UOC by HPLC/UPLC/Microbial 2 Method Development for Assay / UOC by UV 3 Method Development for Dissolution by HPLC/UPLC 4 Method Development for Dissolution by UV Method Development for Related Substances / Compounds by HPLC 5 Forced Degradation, by HPLC/UPLC Method Development for Related Substances / Compounds by HPLC, without Forced 6 Degradation, by HPLC/UPLC

Section 7g: Method Validation, as Per ICH

Sr. No Evaluation parameter 1 Method validation for Assay by HPLC/UPLC with Forced Degradation 2 Method validation for Assay by HPLC, without Forced Degradation Method validation for Dissolution / Preservative Content / Content by HPLC/UPLC 3

Method validation for Assay / Dissolution / Preservative Content 4

Method validation for Related Substances / Compounds by HPLC, with Forced 5 Degradation Method validation for Related Substances / Compounds by HPLC, without Forced 6 Degradation

7 Method validation by GC-FID

Section-7h: Method Development & Validation as Per ICH

Sr. No Evaluation parameter 1 Method development & validation for assay by HPLC, with Forced degradation Method development & validation for Assay by HPLC, without forced 2 Degradation Method development & validation for Dissolution / Preservative content / 3 Colorant / UOC by HPLC/UPLC Method development & validation for assay / dissolution / preservative 4 content / colorant / UOC by UV Method development & validation for Related Substances / compounds by 5 HPLC, with Forced Degradation/UPLC

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Section-7i: Method Transfers / Verifications

Sr. No Evaluation parameter 1 Assay by HPLC/UPLC 2 Assay by UV / Chemical 3 Assay by Microbiology / Antibiotic Assay 4 Dissolution by HPLC 5 Dissolution by UV 6 Related Substances / Compounds by HPLC/UPLC

Section-7j: Stability Storage

Sr. No Evaluation parameter 1 Storage - ICH Conditions 2 Storage - Photo stability 3 Storage - Freeze thaw stability 4 Storage - Sync accelerated stability 5 Full time equivalent service model and Fixed rate contract service model 6 Retention sample /Backup storage/Disaster management storage 7 Controlled substance & Products evaluation 8 Import License

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8. Turnkey & Training

We provide concept-to-completion design laboratory and formulation development Centre for pharmaceutical industry. Our experts will understand your business, possess experience implementing best practices, and will leverage that expertise to enhance your lab's and R&D efficiency. Whether it’s for research or routine testing, our experts can recommend and provide the right solution to address laboratory and development process challenges, helping you drive decisions, maximize resources, and increase productivity. Our operational set up services will ensure regulatory compliance and efficient workflows within a facility. Details of services as follow.

Sr. No Capabilities 1 Needs assessment 2 Process Improvement 3 Complete Automation of process 4 Plan & setting up operation center 5 Multicenter integration process 6 Training programs – Onsite & Offsite Program 7 Expert Laboratory Personnel Training

We will be pleased to talk to you through voice or email, for better understanding of your requirements.

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9. Referral Lab

Poor medicine quality can sometimes lead to serious health consequence & death. Imported or Locally Manufactured Medicines without proper pre & post inspection may be rendered substandard at any point along the medical supply chain, from the point of manufacture through the point of distribution. Regardless of where along the supply chain substandard medicines are compromised, they pose serious public health risks. Use of substandard medicines increases mortality and morbidity and may result in harmful side effects or allergies or engender drug-resistant pathogens that limit the therapeutic effectiveness of legitimate medicines. if contaminated with pathogens result in death.

Substandard medicines undermine governments’ investments in health delivery systems. They erode citizens’ trust in their governments’ ability to maintain and enforce regulatory standards. Their spread also undermines governments’ credibility with respect to providing quality health care. Regulatory body/ Organization Partnering with Stabicon support assist to can address the above challenges by following approaches:

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For any query please contact:

Team Business Development

+91 80 27839259/27839260

[email protected] [email protected]

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