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Dear Readers, Welcome to the latest issue of Micro
The key to making profits in the generic drug market is reaching the market as early as possible by getting proper regulatory approval. Generic medicines play an essential role in the pharmaceutical market because of their lower cost than branded drug molecules. Manufacturers of Generic Pharmaceuticals need not begin from scratch and carry out R&D, preclinical research, and early phase clinical trials.
Instead, they need to show that their drug has a similar Bioavailability and Bioequivalence (BA/BE) as the branded drug. Regulatory bodies carry out a thorough inspection of the manufacturing plant and the clinical trial site and analyze the trial data to check if there has been any data fraud or manipulation.
Generic drug manufacturers thus have to follow the ICH guidelines on good manufacturing, laboratory, and clinical practices to bring a drug ethically to the market.
BA/BE trials are required to prove that the study drug is bioequivalent to the already marketed drug for the same indication. A generic pharmaceutical company always wants to submit BA/BE trial data of their product on time to get regulatory approval to market their drug without any delay. However, developing and executing BA/BE studies ethically under the GCP guidelines is not a cakewalk. Instead, it needs proper planning and a team of investigators, clinicians, medical writers, pharmacokinetics, bioanalytical scientists, biostatisticians, nurses, phlebotomists, and pharmacists. Thus, CROs dealing with BA/BE studies are the choice of many generic drug manufacturers.
India has around 76 BA/BE study centers as of June 10, 2021, under the new clinical trials rule 2019. We present the ten best CROs of Indian origin (headquarter in India) that we consider leading the BA/BE service provider market and have ample opportunity to grow more in 2022.
These ten companies are solely selected based on the data available on their website and the number of years they have been in the BA/BE industry. However, this article does not prove that the other BA/BE CROs are down in performance or not suitable to conduct BA/BE study.
CEO: Jonathan Hunt
Founded in the year: 1993
Group Companies: Biocon, Biocon Biologics, Biocon Academy, Bicara Therapeutics
Key Financial Information of FY 2021:
Companies Net Worth: increased by 10.52%
Operating Revenues: INR 2184 crores (12% growth compared to FY 2020)
Profit After Tax (PAT): INR 382 crores (4% growth)
EBIDTA (earnings before interest, taxes, depreciation, and amortization): increased by 15.14%
Awards and Recognitions (2020 & 2021):
CMO Leadership Award
Bioprocessing Excellence Award
Dream Companies to Work Award
Asian Leadership Award
Top Score Among Indian Pharma in Environment Safety Governance (ESG)
India Pharma Awards
Most Innovative New Learning Programme Award
Best Governed Company in The Listed Segment: Medium Category
Syngene International provides a comprehensive solution for Clinical Development of Generic Drugs.
Till date the organization has successfully completed approximately 700 BA/BE studies. The bioanalytical facility for BA/BE studies is GLP-complaint, spreaded across 7500 square feet and has been successfully audited by the USFDA, ANVISA, UK MHRA, and EMA. Syngene International has more than 150 validated assays developed for BA/BE studies. To know more about Syngene International Limited, visit their website https://www.syngeneintl.com/about-us/#leadership
Director: Ms. Harita Vasireddi
Founded in the year: 1984
Subsidiary Company: Emtac Laboratories Private Limited
Company operational in different cities across India: Hyderabad, Pune, Vizag, Bangalore, Cochin, Ahmedabad, Kolkata, and Nellore.
Companies Net Worth: increased by 12.35%
Operating Revenues: INR 209.05 crores (13.6% growth compared to FY 2020)
Profit After Tax (PAT): INR 21.26 crores
EBIDTA (earnings before interest, taxes, depreciation, and amortization): increased by 75.55%
Vimta Labs have 23 years of experience in execution of BA/BE studies. They carry experience of handling studies of different dosage forms including Injectables, ODS, Patches, Oral Suspensions, and Topical formulations.
They have Experience in conducting BA/BE study on highly variable drugs, BA/BE studies in special populations, patient-based PK studies, 505 b (2) submissions, Apple Sauce fed studies, Steady state studies, and other BA/BE studies involving Complex designs.
To know more about the clinical trial services offered by Vimta Labs, kindly visit their website https://www.vimta.com/what-do-we-do
Founder and Managing Director: Bindi Chudgar
Founded in the year: 1999
Global presence of the company in different locations: India, USA, Representative offices in UK (London), Poland (Warsaw), USA, and Canada.
Companies Net Worth: increased by 19.79%
Operating Revenues: INR 100 cr-500 cr
EBIDTA (earnings before interest, taxes, depreciation, and amortization): increased by 60.69%
Related Post:Top 10 companies that are spearheading the biopharma industryHere is a list of the leading 10 pharmaceutical companies in India
Lambda Therapeutic Research Limited has 21 years of experience, expertise, and capabilities in handling BA/BE studies. The CRO has capability to conduct studies in different dosage forms like injectables, inhalation, topical products, nasal sprays, suppositories, vaginal products, transdermal, ointments, intravaginal and rectal products, and all oral dosage forms. Till date the CRO has experience of conducting more than 7000+ BA/BE studies. Lambda offers global access to 100+ clinical beds inclusive of 85+ specialized beds designed for specific studies. All the facilities of Lambda Therapeutic Research have been successfully inspected by leading regulatory agencies.
To know more about the other clinical trial services offered by Lambda Therapeutic Research Limited and their volunteer database, visit their website https://www.lambda-cro.com/ba-be.php
Founder and Director: Mr. Apurva Shah
Founded in the year: 2004
Group Companies: Bioneeds, Ingenuity Bioscience
Companies Net Worth: increased by 1.19%
Operating Revenues: INR 195.8 crore (22.7% growth compared to FY 2020)
Profit After Tax (PAT): INR 62.9 crore
EBIDTA (earnings before interest, taxes, depreciation, and amortization): decreased by -85.23%
Awards and Recognition:
Biospectrum Excellence Awards 2020: TOP CLRO Company
With 17 years of experience, Veeda Clinical Research has grown to be a Clinical Research Organization of choice for many pharmaceutical and biopharmaceutical companies worldwide. Veeda Clinical research has 77 successful regulatory Audits from regulatory bodies like USFDA, MHRA, ANVISA, WHO, NPRA, ANSM, AGES, MCC, and DCGI.
Veeda Clinical Research has experience in handling BA/BE studies related to
Special population like female volunteers, volunteers with ovarian cancer, and geriatrics.
Complex Generics Studies related to
Long Acting Injectables
PK endpoints and Adhesion study
Healthy Volunteers and patient-based BA/BE studies
Urine PK studies
505 (b)(2) submissions
Fasting and fed BA/BE studies
The CRO has experience of conducting BA/BE studies in healthy volunteers with different dosage forms.
Coming to infrastructure, Veeda CR has:
State of the art negative-pressure room for dosing activity for respiratory medications.
588 BEDS + 20 SPECIAL CARE beds
46 LC-MS/MS MACHINES
45 Deep freezers with capacity to store 11,25,000 samples at -80 ℃
3 Walking type stability chambers with overall capacity to store 34000 Ltr for retention at room temperature
4 Humidity chambers with overall capacity of 3200 Ltr
4 Pharmaceutical refrigerators having storage capacity of 3550 Ltr at 2-8 ℃
To know more about Veeda Clinical Research and their other clinical trial services, visit their website https://www.veedacr.com/
CEO: Vijay Patel
Global presence of the company in different locations: USA (facilities in Florida and Project management in New Jersey), Canada (facilities in Mississauga, Winnipeg, and Scarborough), and Portugal (project management)
Company operational in different cities across India: Ahmedabad, Noida, and Vadodara
Key Financial Information of FY 2021:
Companies Net Worth: increased by 6.34%
Operating Revenues: INR 100cr-500cr
EBIDTA (earnings before interest, taxes, depreciation, and amortization): decreased by -37.47%
Cliantha Research Limited is a full-service CRO with 17 years of experience in handling BA/BE studies for different dosage forms like chewable tablets, suspension, injection, sublinguals, granules, rectal, transdermal, vaginal, nasal spray, gel, lotion, inhalation aerosol, and topical cream.
The CRO has more than 600 validated assays for BA/BE studies and has impeccable regulatory history with USFDA, WHO, MHRA, Health Canada, AGES, AEMPS, MCC, MOH, ANSM, MOPH, ANVISA, CAP, and NABL.
One can find more details about the other clinical trial services provided by Cliantha Research limited through visiting their website https://www.cliantha.com/main/about-us.html
Chairman and Managing Director:
Dr. V. Satyanarayana
Founded in the year: 1994
Companies Net Worth: increased by 2.37 %
Revenue/Turnover: INR 1 cr-100 cr
EBIDTA (earnings before interest, taxes, depreciation, and amortization): decreased by -13.91%
Sipra Labs comes with more than 20 years of experience in providing comprehensive BA/BE services to different leading generic and innovator pharmaceutical industries. Till date, the CRO has an experience of conducting 1600+ BA/BE studies and has more than 150 validated methods. The CRO has 2 clinics with 80 beds facility along with ICU with central online monitoring system for hassle free execution of BA/BE trials in humans. Sipra has supported many global and indigenous pharmaceutical players for their dossier submissions to highly regulated markets like US, Europe and Japan. To know more about the other clinical trial services offered by Sipra Labs in Product Development, visit their website http://www.sipralabs.com/Index.aspx
Founder and Director: Dr. Rajen Shah & Mr. Viraj Shah
Founded in the year: 2002
Global presence of the company in different locations: India, USA (Marketing Team)
Key Financial Information of FY 2021
Companies Net Worth: increased by 16.31%
Operating Revenues: INR 1cr-100 cr
EBIDTA (earnings before interest, taxes, depreciation, and amortization): decreased by -47.01%
Raptim has conducted more than 1100+ BE studies and has about 30,000 healthy volunteer data bases. The CRO has experience in designing and executing BA/BE studies involving psychotropic substances, drugs with long half-lives, teratogenic drugs, endogenous substances, depot injections and many more. Raptim Research is also experienced in conducting BA/BE studies involving non-oral dosage forms and specific populations.
The CRO also has experience and expertise in special studies like In Vivo Tape Stripping studies, Glucose Clamp studies, Skin Blanching studies, Dermal Microdialysis, skin irritation/sensitisation studies, and Veterinary BA/BE studies.
To know more details about the clinical trial services Offered by Raptim Research Private Limited, visit their website https://www.raptimresearch.com/services/ba-be/
Chairman and Managing Director: Dr. Varma S Rudraraju
Founded in the year: 2005
Companies Net Worth: decreased by -0.81%
Operating Revenues: INR 100-500 crores
Total Assets: Increased by 2.03%
EBIDTA (earnings before interest, taxes, depreciation, and amortization): decreased by -48.57%
With over 16 years of experience and capabilities as a CRO in the BA/BE industry, Aizant Drug Research provides the following Pharmacology and Bioanalytical benefits to their clients:
State-of-the-art facilities with global access to 160+ beds
Tie up with multispecialty hospital to perform specific studies
Excellent scientific expertise in handling complex and unstable molecules in BA/BE studies
Excellent services in Medical Writing, Biostatistics, and Clinical Data Management
Robust recruitment & housing options customizable to sponsor / study requirements
Experience of Proof-of-concept studies, Patient PK Studies, Food Interaction Studies, Clinical end point studies and Clinical Trials
Independent ethics committee/ Institutional Review Board
Access to post-menopausal women database
State-of-the art Liquid Chromatography and Tandem Mass Spectrometry (LC-MS/MS) instruments with a capacity of 4000 samples per week
To know more about the other clinical trial services provided by Aizant Drug Research Solutions Pvt Ltd., visit their website http://aizant.com/services.html#BA
Executive Directors: B. Phani Bhushana Reddy, Dr. A. Jayachandra Reddy
Global presence of the company in different locations: India, United States, and Mexico
Key Financial Information of FY 2020:
Companies Net Worth: increased by 31.01%
EBIDTA (earnings before interest, taxes, depreciation, and amortization): increased by 122.61%
Axis Clinicals as a CRO have around 17 years of experience in conducting BA/BE studies for different dosage forms including Solid Dosage Forms (Tablets, Capsules, Soft Gels, Sprinkles, Immediate Release, Extended Release, Delayed Release and Sustained Release), Orally Dispersible Formulation, Liquid Formulations, Suspensions & Syrups, Parenterals (Intra Muscular, Intra Venous & Subcutaneous), Inhalational Dosage Forms (Sprays Nasal & Oral, Metered Dose Inhaler, Dry Powder Inhaler), Transdermal Gel, Dermal Patches, and Skin Blanching Studies.
They also have experience in conducting studies in patient populations (PK/PD studies).
The infrastructure capabilities of the company for BA/BE studies in India include 330 beds (192 beds in Hyderabad and 138 beds in Ahmedabad), Refrigerated Centrifuges, Humidity Chambers, and -30°C and -80°C storage facility.
The company has successfully completed 38 regulatory audits (31 USFDA Audits, 4UK MHRA Audits, 2 WHO Audits, 1 audit from AEMPS of Spain, 1 audit from INFARMED of Portugal, 1 from NPRA of Malaysia, 1 audit from GCC, and 1 audit from MCC of South Africa.
To know more about the other clinical trial services offered by Axis Clinicals, visit their website https://axisclinicals.com/
Managing Director: Krishna Kishore Kuchipudi
Key Financial Information of FY 2021 (standalone basis)
Operating Revenues: INR 41.4 crores
Total Profit: INR 11.3 crores
EBIDTA (earnings before interest, taxes, depreciation, and amortization): INR 18.85 crores
Founded in 1999 as Jeevan Softech Pvt.Ltd, Jeevan scientific technology later started medical writing services in 2011. In December 2014, 15 years after its foundation, the organization inaugurated the corporate and bioanalytical facility which was inspected and approved by CDSCO in March 2015. Jeevan Scientific has started BA/BE studies since 2016. Till date the company has completed 80 Pivotal and 123 pilot studies. The organization has experience in working for different regulatory bodies like USFDA, EMA, Canada, WHO, and PEPFER. Jeevan scientific offers BA/BE studies on oral dosage forms, injectables, suspensions, and liquid dosage form. To know more details about the other clinical trial services offered by Jeevan Scientific, visit their website http://www.jeevanscientific.com/services.php?title=babe-studies.
Note: The Financial Information mentioned in this article has been derived from the annual statement file available in the company’s website and if not available, then the data was collected from Tofler.