Pharmatechy

Principle of Atomic Absorption Spectrometer A solution of metallic salt is sprayed on a flame, and fine droplets are formed. The thermal energy of flame and the solvents in the droplets evaporate, leaving a fine residue, which is converted to neutral atoms. The neutral atoms absorb radiation of a specific wavelength emitted by a hollow cathode lamp(HCL).

HCL is filled with the vapour of elements which gives a specific wavelength of radiation.

The intensity of light absorbed by neutral atoms is directly proportional to the concentration of the elements.

The intensity of radiation absorbed by neutral atoms is measured using photometric detectors.

Note: The excitation of neutral atoms is brought only by radiation from a hollow cathode lamp and not by the thermal energy of the flame.

Instrumentation of Atomic Absorption Spectrometer

Hollow Cathode Lamp

The source of light in AAS is a hollow cathode lamp.

The cathode is made up of specific elements or alloys of elements on the cathode.

When the current is applied to the anode and cathode, metal ions emerge from the collide with filler gas, which is argon. Due to these collisions, the number of metal atoms is excited and emit their characteristic radiation.

This radiation is absorbed by neutral atoms of the same elements in the ground state, which occurs in the flame when the sample solution is sprayed.

For the determination of every element, separate HCL has to be using multi-element lamps.

Ex: Two elements lamps Na/K, Ca/Mg, Three elements lamps Ca/Mg/ Zn.

Burner There are different burners available, which are used to spray the sample solution into fine droplets and mix it with fuel and oxidant.

The most common ones are the Total consumption burner and the Laminar flow burner.

Chopper The instrument had choppers, which rotated as fans allowing alternatively radiation from flame alone or radiation from HCL and flame.

This procedure is a pulsating current signal, which is used to measure the intensity of light absorbed by elements, without interference by radiation from the flame itself.

Monochromator

To isolate the line spectrum of the element from the background signal of the flame. So monochromator that can provide a good resolution of 1 nm is required.

Detector

The intensity of radiation absorbed by elements, in the UV or Visible region (190-800 nm) can be detected phototube or a photomultiplier tube.

Recorder

The recorder readout is capable of displaying the absorption spectrum as well as absorbance at a specified wavelength.

Application of Atomic Absorption Spectrometer

Atomic Absorption Spectrometer is mainly used for quantitative analysis of various elements present in different samples.

Major of the applications are Agriculture, Forensic, Environmental, Food, Pharma, Mining, and petrochemical industries. Estimation of trace elements in biological fluids (ex: blood, urine, etc).

Estimation of elements like copper, Nickel and Zinc, Magnesium, Zinc, Mercury, Lead, etc. Estimation of elements in soil samples, water supply, effluent ceramics, etc.

SOP for Atomic Absorption Spectrometer

Company Logo Company Name, Unit, Address, Area

TITLE: Operation and Calibration of Atomic Absorption Spectrometer

SOP No. QC-XX, Department: Quality Control Revision No.0.0 . Page No.xx of Effective Date: xx. yy. ZZ Review Date: 3 yrs from the effective date

PURPOSE

This procedure describes the Operation and Calibration of the Atomic Absorption Spectrometer

SCOPE

This procedure applies to the QC departments at the Company name, Unit, and Address.

ABBREVIATIONS

AAS: Atomic Absorption Spectrophotometer.

FAAS: Flame Atomic Absorption Spectrophotometer.

GFAAS: Graphite Furnace Atomic Absorption Spectrophotometer. VGA: Vapour Generation Accessory.

Abs: Absorbance

nm: Nanometer

ppb: Parts per billion

ppm: Parts per million

RSD: Relative Standard Deviation

NLT: Not Less Than.

NMT: Not More Than

QC: Quality control

QA: Quality Assurance

RESPONSIBILITY

Analysts/Users are responsible for following this procedure.

QC Manager / Designee is responsible for the implementation of this procedure.

QA Manager / Designee shall monitor compliance with this procedure.

Safety Precautions

Operate the spectrophotometer with the flame shield closed and the sample compartment front panel in place.

Use the correct burner head for different flame modes.

Do not ignite the flame without a burner head and nebulizer and also when the water level is too low in the liquid trap.

Do not use flammable solvents in or near the AAS which can create an explosion.

Always use the correct acetylene flow for Nitrous oxide – Acetylene mode. This mode will produce carbon deposits, making sure the extraction equipment above the instrument is working correctly.

Always empty and clean the liquid trap after completion of analysis. Never use a solvent having a weight per ml lower than 0.76.

Operation of Atomic Absorption Spectrometer

Flame Mode

Switch on the instrument. Check all the tubings for gas leaks. Select the gas either air-acetylene or nitrous oxide-acetylene as per the method.

Place the hollow cathode lamp, mention the current, and perform an optical set-up. Ignite the flame and allow it for a few minutes to stabilize.

Carry out adjustments for flame height, gas flow rate, and burner position to obtain maximum absorption signal.

Ensure that a real-time graph is displayed. Aspirate deionized water and auto-zero the absorbance signal.

Click the start icon followed by calibration and sequence. GFAAS Mode Switch on the instrument. Check all gas leaks.

Turn on the hollow cathode lamp, and/or perform an optical setup, and allow the lamp to warm up. Switch on the cooling water supply and argon gas with an exit pressure of 70 psi. Set furnace heat program.

Choose the composition of the wash liquid to efficiently remove traces of the sample solutions from the capillary. Dilute nitric acid (approximately 1% v/v) will be suitable for many aqueous sample types.

The autosampler capillary tip must be aligned with the cuvette injection hole before use. Set the Argon gas supply. Turn on the water supply.

VGA Mode

Switch on the spectrophotometer install the Hydride generator parts and connect. Turn on the hollow cathode lamp, perform an optical setup, and allow the lamp to warm up. Prepare the reagents, sample as required, and place them in the containers Set the heating element and quartz tube on the burner head.

Set the temperature for the hydride generator. Connect the Argon tubing. Define sequence and start analyzing.

Startup AAS Software> Turn on power >Run mode >Analysis> Initialization >Set the Element lamp, Select the element a, and Set the Element Lamp >Peak search and wavelength scan >Set the instrumental parameters ( Optical and measure method )> Set the elemental measurement parameters > Optimize the atomizer position for furnace mode> Set the sample > Standard concentration set-up> Select the Correction Method, Curve equation, concentration unit, sample > Select the measurement parameters and perform the measurement

Calibration of Atomic Absorption Spectrometer

Flame System Sensitivity Check Measure 2.0 ppm Copper standard solution. Acceptance Criteria: The average of seven absorbance readings should be NLT 0.280 Abs&% RSD should be NMT

1. Linearity in Flame Mode

Perform Linearity with at least three calibration points for Zinc (213.9 nm), Copper (324.7 nm), and K (766.5 nm).

Acceptance Criteria: Regression should be NLT 0.99

GFAAS Sensitivity Check

Measure 20 µL injection of 20 ppb Copper standard solution Acceptance Criteria: The average of seven absorbance readings should be NLT 0.06 Abs & % RSD should be NMT 5.

Perform Linearity with at least three calibration points for Lead (283.3 nm)

Acceptance Criteria: Regression should be NLT 0.99

VGA MODE (Hydride Generator). Linearity: Perform Linearity with at least three calibration points for Mercury.

Acceptance Criteria: Regression should be NLT 0.99.

Linearity in Flame Mode

Perform Linearity with at least three calibration points for Copper (324.7 nm)

Acceptance Criteria: Regression should be NLT 0.99

Linearity in GFAAS Mode

Linearity: Perform Linearity with at least three calibration points for Mercury.

Acceptance Criteria: Regression should be NLT 0.99Perform

Linearity with at least three calibration points for Lead (283.3 nm)

Acceptance Criteria: Regression should be NLT 0.99

VGA MODE (Hydride Generator) Calibration Frequency: Once in six months.

Maintenance: Check the exhaust system using the smoke. Check the acetylene cylinder pressure.

Ensure that the acetylene is not drawn into the instrument. Inspect the gas hoses for any damage.

Turn on the gas supplies to the instrument and check all hoses and connections for leaks. Check water connections for GFAAS operation. Check the burner for deposits. If any, soak with detergent and clean with distilled water.

At frequent intervals inspect the inside of the graphite shroud which is mounted at the center cooling block.

Using a cotton bud or similar material, ensure that the bore and injection hole are free from loose carbon or sample residues.

REFERENCES

AAS User Manual

REVISION HISTORY

Version no. Effective date Summary of revision

0.0 xx. yy.zzzz New SOP

END OF THE DOCUMENT

Prepared by Reviewed by Approved by Executive-QC QC Manager Manager-QA

https://pharmatechy.blogspot.com/2022/05/sop-for-polarimeter.html

The Quality Assurance department plays a major role in the Pharmaceutical industry. The quality of the products that are manufactured in the production areas from starting to following and reviewing documents from the final release or rejection of every batch of Drug substance and Products for distribution and sale. QA department ensures every stage of manufacturing of the drug substance or drug product and also monitors each processing stage and maintains all manufacturing-related documentation as per BPR, Standard Operating Procedures (SOPs). The most important activity for in-process manufacturing and critical process and quality parameters checks up to batch release. Examples: Clean condition and proper manufacturing area, temperature probes, Pressure, steam, RT water, brine, and Personal protective equipment. IPQA persons monitor the in-process and control. After completing the manufacturing batch process record reviewed all data related to product manufacturing like line clearance, raw materials, temperature times, pressure, chemist signature, any deviations, time delays etc., and a checklist of all the calculations related to Batch Processing Records(BPR). Ex: Yield calculations Type complaint based on quality and safety QA responsible action for the decision taken by HODs as per SOPs. Change Control (CCF): Any changes based on minor or major processes and validation applied required a change control form which the department finally reviewed and approved by QA within timelines. These are two types based on product quality 1) Temporary 2) Minor deviation 3) Major deviation

Deviation: The deviation is the observation of any process-related information that deviates from the standard process or Protocol. These are two types based on product quality 1) Major deviation 2) Minor deviation In case of any out results from testing given Specification Standard testing procedure. QA department investigates to find the root cause of results Out of Specification (OOS): The results are coming out of the specification These are two types of investigations. Phase 1: Laboratory investigation (Quality Control) Phase 2: Full-scale investigation (Manufacturing, warehouse and Safety) and also additional tests required for investigation. Find out the root cause of the results and decide to take corrective and preventive action so these are not repeated in future. Out-of-trend (OOT): The results are within the specification limits but do not follow the previous batch trend results and are also near the specification limits.

The Quality Control department's major and important role is in the Pharmaceutical industry.

The main role of the quality control department in the pharma industry is to check the quality of various products, such as raw materials, in-process samples, and finished products.

Their main agenda is to analyse and control the quality of the products at all stages of the manufacturing of API or Formulations.

QC is done by the Qualitative and Quantitative analysis of specific materials as per Stanard Testing Procedures (STP) or Method of Analysis.

Generally, the QC department is divided into four sections. These are main

Raw Materials

In-process Quality Checks (IPQC)

Finished Products

Stability Studies

Raw materials:

The materials come from outside industries or suppliers and road tankers check the quality of the materials as per in-house specifications or Standard testing procedures. 

These are categorised into four parts.

General Raw materials:

These are some chemical analyses, like titrimetry, and chemical analysis methods, such as organic and inorganic acids, bases, salts, etc.

Ex: Hydrochloric acid(HCl), Sulphuric acid(H2SO4), Nitric acid(HNO3), Caustic soda(NaOH), Sodium carbonate(Na2CO3), Methanol, Toluene, Acetone, Dichloromethane etc…

Key Starting Materials (KSM):

These are the building blocks of drug intermediates or used to form the structure of compounds, APIs, or Drug substances. 

The sampling method is different from general raw materials.

These are analyzed with both chemical and instrumental analysis.

Ex: Speciality Fine Chemicals, Drug Intermediates etc.

Packing Materials:

PM is used for Products/Compound materials that are stored

Ex: Fibre drums, HDPE, LDPE drums, Polyethene bags, etc…

Hazardous Materials:

HM are harmful or affect body raw materials to handling in careful safety precautions and as per its Material Safety Data Sheets (MSDS) so vendors or suppliers give a certificate of analysis based on these are approved as per customer COAs.

Ex: Sodium Hydride(NaH), Sodium Amide(NaNH2), NaCN etc…

Some catalysts are also approved as per customer COAs

Ex: Raney-Nikel, Palladium/Carbon(Pd/C) used for Hydrogenation reaction.

In-Process samples:

Online chemical and instrumental methods analysis as per in-house specification & STPs carried out samples coming from the manufacturing blocks or production department to time to give results after the process continuously.

Finished Products:

Complete Analysis carried out as per customer or In-house or Pharmacopia specification and Standard Testing Procedures of the final products.

The analysis carried out in the Quality control department is divided into two parts. These are

Chemical Analysis Laboratory (Wet Lab)

Volumetric analysis:

Chemical labs have five types of titrimetric analysis

Acid-Base Titration Ex: Hydrochloric acid (HCl), Sodium Hydroxide (NaOH)

Argentometric titration Ex: Sodium Chloride(NaCl), Aluminum chloride (AlCl3)

Redox Titration Ex: Sodium thiosulphate, Potassium permanganate

Complexometric titration Ex: Calcium chloride (Cacl2), Magnesium (Mg) and Metals

Non-aqueous titration for Drug intermediates and APIs Ex: 2-Amino Pyridine, Isonipotic acid etc..

Gravimetric analysis:

Gravimetric analysis is the mass of an ion in a compound and is determined to find out the mass per cent of the same ion in a known quantity of a compound.

Examples 1) The amount of sulphate as barium sulphate(BaSO4) from sodium sulphate(NaSO4).

2) Content of Nickel in Raney-Nickle catalyst and Palladium in Pd/C catalyst.

Wet laboratory, some important chemical analyses are

Ex: Water content(WC), Loss on drying(LOD), Residue on ignition(ROI), Specific Optical Rotation(SOR), Wt per mL, Thin Layer Chromatography(TLC), Tapped density, Friebilty, Dissolution, Disintegration etc.

Water Analysis:

Softener water: This water is used for boiler purposes to generate steam.

Demineralized or Deionised water: This water is used for chemical analysis and process areas.

Purified water: This water is used for the manufacturing process.

Three samples are collected to be analysed to their specification (WHO) and Standard testing procedures as per scheduled.

Instrumental methods of Chemical analysis

1) Chromatography: 

Instrumental analysis to analyse quantitative and qualitative investigates analytes using the help of scientific instruments.

There are main two instrumental analyses carried out for Quality Control in the Pharmaceutical industry.

This technique separates and identifies the mixture of the compounds based on their relative affinity amounts of each compound distributed between a moving mobile phase, and a stationary phase. Mostly used instruments of Quality Control in the Pharmaceutical industry

          1) High-Performance Liquid Chromatography (HPLC)           2) Gas Chromatography (GC)

2) Spectrophotometry:

Spectroscopic techniques are to pass a beam of electromagnetic radiation onto an unknown sample and observe to find out the difference between energy levels with reference.

Most commonly used spectrophotometers of Quality Control in the Pharmaceutical industry. There are 

           1) Ultra-Violet Spectrophotometer (UVS)            2) Fourier-transform infrared spectrometer (FTIR) and NIR  3) Atomic Absorption Spectrometer (AAS) and FAS

These are the main used Research Centres for Structure elucidations and Analytical Method Development.

          1) Nuclear Magnetic Resonance Spectrometer (NMR)

          2) Mass Spectrometer (MS)

3) Thermo Gravimetric Analysis (TGA)

4) Differential Thermal Analysis (DTA)

Stability Studies:

Stability studies are conducted for a re-test or expiry or a shelf life period for the drug substance or the drug product and recommended storage conditions.

These are analysed as per protocol or stability STP based on the schedule.

           1) Hold-time stability studies            2) Long-term, Accelerated, intermediate condition studies

The quality control department follows systematic proper online documentation, Logbooks, Registers, Good Laboratory Practices (GLP) and Good Documentation Practices.

After complete analysis, documented respective analysis signed and checked authorised persons to prepare the certificate of analysis approved by the Head of the department or Designee.

Backup Electronic Data:

All electronic data stored in their servers or external hard disks are Empower network or Lab solution or Open Lab software and its data is backed up and retrieved every week by an IT person.

 Conclusion:

Drug Substance: A drug substance or API is used to cure or prevent disease in the body. An API is a manufactured drug intermediate used to synthesise organic substances.

APIs add some excipients dosage form shapes like tablets, Capsules, Pellets, and Injectables in formulation development, they are chosen so that the active ingredient can reach the cure in the body.

Examples: OMEE tablets contain Omeprazole an API or Drug substance The drug item is a drug substance and excipients, dosage form which are the fixings of the tablet, Capsules, Orals or the liquid in the active agent is suspended or pharmaceutical form.

Drug Product: A finished product form like a tablet, capsule, or oral that contains an active pharmaceutical ingredient, generally, in association with inactive ingredients.

Examples: OfloxOZ tablets are a sedate item dose form that contains Titanium oxide colour specialists, OfloxOZ tablets are a drug product dosage form that contains Titanium oxide colour agents, Ofloxacin and Ornidazole are drug substances or active pharma ingredients. Pharma excipients are substances contained in a pharma dosage form, with no direct therapy action for the manufacturing process, to protect, and support for bioavailability.

Excipients: Antiadherents, Binders, Coatings, Colours, Disintegrants, Flavours, and lubricants. The difference between the API (DS)and finished form (DP)is the drug substance is the active pharmaceutical ingredient that is used to make the drug product, a pure material with pharmacological action on the body.

The drug product is the combination of a drug substance or two or more drug substances or excipients. Tablets, capsules or injections are known as drug products.  while the active part which exerts action on the body and is present in tablets, capsules or injections is known as a drug substance.

Key Raw Material: The key raw material used in the production of API intermediates or API API starting materials is a significant structural fragment in the structure of the API.

An API Starting Materials is a material purchased from one or more approved vendors under contract manufacturing units or commercial agreement suppliers or produced in-house. Formulations: The formulation is a process which different from API processes, including the active pharma ingredient, which is the combination of excipients to produce a drug product.

* The Top 10 Pharmaceutical Companies in India are ranked by their revenue and market capitalization.

* India is the largest provider of generic medicines, holding a market share of 25% of the global supply by volume and meeting 61% of the vaccine requirement worldwide.

* Indian Pharmaceutical companies also supply 81% of antiretroviral medications (HIV/AIDS) in the worldwide markets.

* The international pharmaceutical market is anticipated to surpass USD 1.27 trillion by 2023. India is one most suitable states in this worldwide pharma market. India provides more than 55% of the worldwide purpose for different vaccines and 45% of the demand for generic medicines in the United States. India’s pharmaceuticals demanded to expand at 11% CAGR during 2023 to reach 33 Billion US dollars.

1. Sun Pharmaceutical Industries Ltd * Sun Pharmaceutical Industries Ltd is an Indian multinational pharmaceutical company founded by Dilip Shanghvi in 1983, Vapi, Headquarters Goregaon, Mumbai, India, And Subsidiaries of Ranbaxy Laboratories, etc. It produces and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in India also the United States. It provides formulations in psychiatry, cardiology, dialectology, neurology, and gastroenterology. * Sun Pharma supplies APIs such as etodolac, clorazepate, carbamazepine, warfarin, anti-cancer drugs, peptides, steroids, sex hormones, etc. It supplies more than 2000 formulations and also exports to various other countries. * The main features of Sun Pharma are research and development facilities and its own APIs. It supplies more than 2000 formulations and also exports to various other countries. The main features of Sun Pharmaceuticals are research and development facilities and its own APIs.

2. Dr Reddy’s Laboratories Ltd Dr Reddy’s Laboratories is an Indian multinational pharmaceutical company founded by Kallam Anji Reddy in 1984, in Hyderabad, India. The company produces pharmaceutical formulations and active pharmaceutical ingredients (APIs) in India and other countries and more than 195 drugs, and 65 APIs for drug, and biotechnology products. DRL has six API units(CTO)and four Formulation(FTO) manufacturing plants across India. Its main focus research and development centres are Integrated Product Development Organization (IPDO) and Custom Pharmaceutical Services (CPS) located in Hyderabad, India.

3. Divi’s Laboratories Ltd Divis Labs is an Indian pharmaceutical company founded by Murali Divi in 1990, in Hyderabad, India. It manufactures APIs, Intermediates, and Nutraceutical ingredients. Divis Labs have three manufacturing units located at Chouttal, Hyderabad, Chippada, Andhra Pradesh, and 3 Research and development centres. The Company exports the products to the USA, Europe, Japan, South Africa, Australia, and the Philippines.

4. Cipla Ltd * Cipla is an Indian multinational pharmaceutical company founded by Khwaja Abdul Hamied in 1935, with Headquarters in Mumbai, India, And supplies top-quality generic medicines in India. * The company supplies a wide range of medicines. It has a prominent position in the Indian market and global market and in more than 150 countries. The company provides quality products worldwide received approvals from major regulatory agencies and more than 2000 formulations cover areas like neurology and nephrology. It has a global focus on the important markets of India, the US, and South Africa.

5. Aurobindo Pharma Ltd * Aurobindo Pharma is an Indian pharmaceutical company founded by Nityananda Reddy started operations in 1988 with a single unit manufacturing Synthetic Penicillin at Pondicherry and became a public company in 1992 headquartered in HITEC City, Hyderabad, India. The company has provided key therapeutics like cardiovascular, antibiotics, gastroenterology, anti-diabetics, and anti-Allergics. APL exports products to more than 160 nations in the world. Aurobindo Pharma has production, research, and development and Subsidiary units are Novagen Pharma, AuroZymes Ltd, etc.

6 Torrent Pharmaceuticals Ltd * Torrent Pharma is an Indian pharmaceutical company founded by Uttambhai NathalalMehta in 1959 Headquarters in Ahmedabad, India. started as Trinity Laboratories Ltd, and renamed Torrent Pharmaceuticals Ltd, nowadays. It is ranked the leader in the therapeutic sector of women’s health care, cardiovascular, CNS, gastrointestinal, diabetology, oncology, gynaecology, and anti-infective. They have first-class manufacturing units, R & D facilities, and a prevalent international presence in more than 50 nations. The company had procured Elder Pharma’s Indian company, Zyg Pharma, the API plant of Glochem Industries, Unichem’s Sikkim Plant, Bio-Pharm Inc., generic pharmaceuticals, etc. 7. Lupin Ltd * Lupin is a multinational pharmaceutical company founded by Desh Bandhu Gupta in 1968 in Mumbai, India. A large range of products like Branded & Generic Formulations, Biotechnology Products, APIs, and manufacturing centres are across India, Japan, Brazil, Mexico, and the United States. Subsidiaries are Novel Laboratories, Polynova Industries, and GAVIS Pharmaceuticals. The company is in the treatment areas of Non-Steroidal Anti-Inflammatory Drugs, Cardiovascular, Gynaecology, Asthma, Paediatric, Diabetology, Gastro-Intestinal, and Anti-Infective drugs, Anti-TB and Cephalosporins sectors. The company has moved around more than 100 countries. It supplies top-quality medications. The company is in the treatment areas of Non-Steroidal Anti-Inflammatory Drugs, Cardiovascular, Gynaecology, Asthma, Paediatric, Diabetology, Gastro-Intestinal, and Anti-Infective drugs, Anti-TB and Cephalosporins sectors. The company has moved around more than 100 countries. It supplies top-quality medications.

8. Zydus Cadila Healthcare Ltd * Zydus Cadila is a fully integrated Indian Pharmaceutical company founded by Ramanbhai B. Patel in 1952 in Ahmedabad, Gujarat India. It provides Active pharmaceutical ingredients, formulations, and animal healthcare products to wellness products. The company’s research and development facilities are in Gujarat, Maharashtra, Goa, Himachal, and Sikkim as well as research units in the US and Brazil. It has 1400 researchers across 20 sites, working on medicines and exploring various ideas from NCEs to vaccines, and bio-similar products. The company’s global business has regulated markets in the United States, Europe, South Africa, Latin America, and also 30 other national markets in the world.

9. Abbott Pharma India Ltd * Abbott India Limited is a Pharmaceutical company founded by Dr Wallace Calvin Abbott in 1944, in Mumbai, India, and a subsidiary of Abbott Laboratories United States. It manufactures pharmaceutical drugs, therapeutics for Women’s Health, Neurology, Thyroid, Gastroenterology, Anti-Infective, Diabetes, Urology, Pain, Vitamins, etc., and a plant at Verna, Goa. It has to produce high-quality formulations, branded generic pharmaceuticals, diagnostics, medical devices, and nutrition.

10. Alkem Laboratories Ltd * Alkem Laboratories is a Pharmaceutical company founded by Samprada Singh in 1973, in Mumbai, India. It provides quality branded generics, generic medications, APIs, and nutraceuticals in India, and more than 60 countries worldwide. Alkem has been ranked as the No.1 Anti-infective company in India for more than ten years and also has therapeutic segments for gastrointestinal, Vitamins, Minerals, Nutrients, and pain management.