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Apogen – Jodas Expoim 
Apogen entered into an MOU with Jodas Expoim Pvt Ltd, a Company promoted by NRIs based in Russia for offering Technical Consultancy right from designing to commissioning of their Sterile Formulations Manufacturing Facility. Jodas has a well established market in Russia and CIS countries with turnover in excess of Rs. 100 Crores. The facility is coming up in Genome Valley, Biotech Park, Phase III, Karkapatla, Medak District. The First Phase activity will be the establishment of three Dedicated Manufacturing Blocks one each for manufacturing of Cephalosporins in the form of Dry Powder Injections, Oncology Products in the form of Lyophilized and Liquid Injections and Oral Solid Dosage forms and Carbapenems in the form of Dry Powder Injections and a separate block for the Formulations Research and Development in a plot of Ac 7.00. We are working hard to bring the facilities for the commercial production by the end of 2014. The total constructed area in the First Phase will be nearly 2,00,000 SFT.
The Second Phase activity will be the establishment of three more dedicated Manufacturing Blocks one each for manufacturing of Contrast Media, General Injectibles and & Prefilled Syringes and Oral Solid Dosage Forms in a plot of Ac 7.89. The second phase activity will be commenced by the end of 2013. The total constructed area in the Second Phase will be nearly 2,50,000 SFT. The total project outlay for both phases is estimated at Rs. 100 - 120 Crores.
Two more similar proposals for our Consultancy services are in the pipeline and one among them is at a fairly advanced stage.
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Established in 2007 with focus in the area of Pharma Education & cGMP Training for professionals working in Pharmaceutical, Biotech, Medical Device, Cosmetic and Food and Nutritional Product Manufacturing Industries, Bhan Pharmainfo, now a sister concern of Apogen, pioneered the support education and are the first in India to introduce the Course of MS Pharmaceutical Technology for the working professionals with Procedures, Practices and Documentation as Major Curricula. Today we can proudly claim of a student base about 700 which includes middle to senior level executives of Top 100 Pharmaceutical companies of India.
Our above course was an instant success because we could successfully address the gaps in knowledge imparted by the academic institutions and the present day needs of the higly regulated Industry. Our consultants who put in considerable experience overseas, feel that similar is the case with many other countries world wide. Hence, we can design and implement suitable courses for personnel in your industry / Institution.
After an enviable run of success in imparting Quality Education & Training, Bhanpharmainfo Pvt. Ltd, now under Apogen banner endeavours to provide Pharma Consultancy services in the areas of Human Resources, Contract Research & Manufacturing Services, Clinical Research, Market Research and Strategy for National & International Markets.
With our well connected global network and team of highly qualified, Trained & experienced professionals, we explore the gaps and opportunities in the global Pharma arena by an in depth research and analysis. We develop and design our services and products to suit your needs enabling you to meet the future needs of your business there by ensuring your success in this highly competitive global market.
We offer Technolution services in drug development and Clinical Studies to the world Pharma industry
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| We offer |
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Excellent guidance in understanding of 21st Century Quality Initiatives of FDA for QbR, QbD, & PAT (ICH GL 8,9, 10 and 11) |
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A stepwise implementation plan for Robustness of Processes based on fundamental principle of QbD and Design Space |
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Technolution services in drug development and Clinical Studies to the world Pharma industry |
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| Formulations Development: |
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Special emphasis on 'high barrier', 'high potency' compounds in solids, liquids, topical, MR, Parenterals, and novel dosage forms |
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| Technology Transfer: |
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Formulation & Process Optimization, Trouble Shooting, Technology Transfer from Development to commercial, outsourcing phases etc. |
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| Regulatory Affairs: |
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| Preparation and/or Review of CMC sections for NDA and ANDA submissions with expertise in eCTD and also providing advice in the following areas: |
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Deficiency letters in CMC, Bioequivalency and Labeling |
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Interaction with Regulatory Agency to resolve issues related to approval |
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Writing and/or Review of Reports related to: |
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• Development
• Optimization
• Technology Transfer
• QOS
• Executive Summaries and others as required
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| Bioequivalence Services: |
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We can help client companies identify suitable CROs (Clinical Research Organizations) in India, Canada and the USA for carrying out bio studies. |
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Designing bio studies and interpreting the bio data |
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Advice on IV/IVC if such studies are feasible or not |
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Advising formulators on the necessary formulation changes to have successful bioequivalence |
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Providing excellent guidance in understanding of 21st Century Quality Initiatives of FDA for QbR, QbD, & PAT (ICH GL 8,9, 10 and 11) |
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Providing a stepwise implementation plan for Robustness of Processes based on fundamental principle of QbD and Design Space |
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SOP creation and review |
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GMP compliance |
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System based approach to quality |
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| Setting up of a Generic Business |
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We can set up your company as one of the substantial generic businesses, which include services starting from 'molecule' to 'market' |
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We can also design and equip facilities for Pharma development/manufacturing |
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| We have carried out several projects successfully for manufacturing of tablets, capsules, oral suspensions (antibiotics), injectables (antibiotics), & oral liquids. |
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| Seminars, Training, and Lectures on: |
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A Seamless Technology Transfer (Model consisting of Strategy, Concurrent Database Collection, and Case Histories) |
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Bioequivalence and IV/IVC |
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Development for Solid Dosage Forms (Traditional Tablets and Capsules, chewable Tablets, ODT, etc.) |
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Development of Modified Release (MR) Dosage Forms |
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Development of Scheduled drugs with deterrents (avoid abuse potential) |
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Development of Target Drug Delivery System |
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Fluid Bed Coating (multiparticulate coating) |
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Handling of Controlled Substances |
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How to Prepare e-CTD Submissions |
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Improving Bioavailability of Poorly Soluble Drugs |
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Outsourcing, What, Why, Where, and How? |
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PAT, QbD, QbR, and e-CTD (21st Century GMP Initiatives by FDA) |
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Physicochemical Characterization of APIs and Excipients |
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Selection of Excipients (for generics and brands based on complying regulations as applicable) |
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Tablet Film Coating (functional and non-functional) |
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| Significant Accomplishments of Adnan Sabir, Principal Consultant |
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Received a U.S. Patent 5,316,772 on ‘Bilayered Oral Pharmaceutical Composition with pH Dependent Release’, May 31, 1994 |
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Received ‘Excellence’ reward from GlaxoSmithKline for completing two priority projects on fast track |
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Established miniaturized processing equipment/process for typical unit operations in OSD |
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Managed a team of 120 scientists through 4 DRs., which included resource allocation, career development, hiring, performance objectives/appraisals, merit increases, and bonuses |
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Developed several Oral Contraceptives (potent drugs) at Watson from formulation, development to approval |
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Successfully transferred a ‘Troche’ dosage form from lab scale to production scale overcoming the challenges of compressing the unique shape, stick insertion, printing, and safety of potent schedule CII drug |
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Designed Optimization laboratory and Pilot Plant facility for manufacturing of cGMP batches at Dr. Reddys Lab in India |
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Established systems and procedures for a seamless flow of drug development from lab to commercial usage stage |
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Transferred a directly compressible AQFC antiviral tablet, Ziagen, to GSK’s UK and US Units |
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Successfully developed, optimized, and transferred (to various sites globally) solid and liquid formulations, in brand and generic pharma industries. Such dosage forms included Tablets, Capsules, Solutions, Suspensions, Soft gels, and Sustained Release Products utilizing geomatrix, MUPS, IER, and minitablets |
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Developed, scaled-up, optimized, manufactured, filed and finally got approval from FDA a sustained release resin suspension using Penn kinetic technology |
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Developed erations |
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Served as a team leader for several projects in the manufacturing of Clinical Supplies for NCEs from Phase I to IV Compiled and wrote CMC sections of INDA, NDA, ANDA, & MAA for international submissions and US. Responded to deficiency letter with justifications when required |
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Supervised the procedures and systems for the inventory of 'CONTROLLED' substances |
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| Available Knowledge & Resources |
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We can provide competent candidates, with B. Pharma., B.Sc., Masters and Ph.D. degrees with rich experience ranging from 3 to 30 years, for serving as full-time / part-time and / or as consultants
With such high academic qualifications and rich and varied experience, positions at all levels, from Tech to Senior Management, can be filled up
What We Expect from Our Client:
Straight Talk, Ethical, Legal, Respectful, Transparent Dealings etc.,
What the Clients can Expect from Us:
Quality Services, On Time Deliveries, Honest, Responsible, Reasonable, Flexible Dealings etc.,
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