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    Company profile for Alembic Pharmaceuticals Limited

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

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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    About

    Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.

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    INTERVIEW #SpeakPharma

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    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

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    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    Artificial intelligence (AI) is emerging as a transformative force in drug discovery and development. The global AI in drug discovery market was valued at US$ 1.99 billion in 2024 and is estimated to reach US$ 2.65 billion in 2025. Going forward, the market is expected to grow at an impressive compounded annual growth rate (CAGR) of 29.6 percent, to reach a market size of US$ 35.42 billion by 2034, says a report by Polaris Market Research. This growth expectation mirrors the eagerness within the biopharma industry to leverage AI in order to overcome the traditional barriers of lengthy timelines, exorbitant costs, and high failure rates. This eagerness is also being manifested in deal making — Big Pharma has been busy forging alliances with AI-driven drug discovery companies. Over the last two years, almost every big drugmaker, including Novo Nordisk, Merck, BMS, Pfizer, AstraZeneca, Otsuka Pharmaceutical, Novartis and Sanofi, has signed deals with various AI drug discovery companies. PharmaCompass' compilation shows there are scores of molecules discovered by AI currently in discovery and developmental phases, demonstrating the technology's growing impact on pharmaceutical pipelines.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available) Novo, Lilly, BMS invest in AI partnerships; Recursion, Exscientia merge to create AI powerhouse With the transformative potential of AI becoming increasingly evident, we witnessed a slew of deals in the biopharma industry over the last six months. A significant deal in the AI drug discovery space was the merger of two leaders — Recursion and Exscientia — that took place in November last year. Exscientia is now a wholly-owned subsidiary of Recursion. The merger has created a global technology-enabled drug discovery leader with end-to-end capabilities. The merged entity has over 10 clinical and preclinical programs, and around 10 advanced discovery programs in the pipeline.  Apart from this merger, several large drugmakers have struck deals with AI drug discovery firms since September last year. For instance, in January this year, Valo Health and Novo Nordisk expanded their collaboration to discover and develop novel treatments for cardiometabolic diseases. This deal, valued at up to US$ 4.8 billion, aims to harness the power of AI and extensive human datasets. Building on their initial 2023 partnership, it will enable the development of up to 20 drug programs.  Similarly, Pfizer, which is already big on AI, extended its AI drug discovery pact with PostEra and also partnered IgnitionAI to enhance drug discovery — all within the last six months. And Novartis struck a drug discovery deal with Generate BioMedicines in September. Insilico Medicine has been actively forging partnerships. In January, Insilico entered a second exclusive global license agreement with Menarini Group for an AI-discovered preclinical asset targeting high unmet needs in oncology. Insilico also has a tie-up with Sanofi, dating back to 2022. In December 2024, AI Proteins announced a research collaboration and option agreement with BMS to design and optimize mini-proteins for therapeutic use. And in September, Eli Lilly joined hands with Genetic Leap to accelerate the development of genetic medicines. Lilly will leverage Genetic Leap’s RNA-targeted AI platform to generate oligonucleotide drugs against selected targets.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  AI leads to faster target identification; Insilico, BenevolentAI’s candidates in trials Computational biology, and especially AI, has fundamentally changed the drug discovery paradigm. The traditional method of drug discovery used to take 13 to 15 years, costing an average of US$ 2.5 billion in investment before a drug got approved and launched in the market. Additionally, less than 10 percent of candidates in phase 1 clinical trials used to end up getting approved by the US Food and Drug Administration (FDA). All that has begun to change. According to Khair ElZarrad, Director of the Office of Medical Policy within FDA’s Center for Drug Evaluation and Research, since 2016, FDA has received approximately 300 submissions that reference AI use as of May 2024. These submissions range from drug development, drug discovery, clinical research, clinical trials as well as post-market safety surveillance and manufacturing. Though we are yet to witness an AI-generated candidate translate into an approved therapy, target identification in drug discovery is visibly becoming a lot faster. This is the process that identifies specific molecules or pathways in the human body that are linked to a disease. The best example of dramatic acceleration of timelines is Insilico Medicine’s development of INS018_055, a candidate for idiopathic pulmonary fibrosis that entered phase 2 trials in June 2023. Using their AI platform PandaOmics, researchers at Insilico compressed target identification from years to just 18 months. Similarly, BenevolentAI successfully employed their AI platform to identify a new target for ulcerative colitis, leading to the development of BEN-8744, a candidate that has been in phase 1a clinical trials since August 2023.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Oncology leads AI drug discovery market; Recursion shows how to repurpose drugs using AI The integration of AI in oncology research has been impactful, accounting for the largest revenue share (about 22.4 percent) in the AI drug discovery market in 2023. AI technologies have accelerated the discovery and development of new cancer treatments, bolstered personalized medicine approaches, and improved clinical trial designs in the arena of this complex disease.  Another promising application is drug repurposing, where AI can identify new therapeutic applications for existing drugs. Recursion Pharmaceuticals’ REC-2282 exemplifies this approach. This therapy is currently in phase 2/3 studies for neurofibromatosis type 2 (a genetic condition that causes tumors to grow along nerves). By repurposing compounds already vetted for safety, this strategy can bypass early-stage failures, reducing both time and cost compared to developing entirely new molecules. However, the use of AI in drug discovery is not without challenges. Exscientia’s EXS-21546, designed to treat solid tumors, entered phase 1/2 trials in 2020 but was discontinued in 2023 after modeling suggested that achieving a suitable therapeutic index would be difficult. Though this is a clinical failure, it highlights AI’s value in identifying potential failures earlier on in the development process, saving resources that would have otherwise been spent on later-stage trials.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Our view The Covid-19 pandemic was a time when humanity felt the urgent need to speed up the process of drug discovery, testing and approvals. It also hastened the process of integrating AI into pharmaceutical research, leading to the launch of Covid vaccines in record time. Today, there is no looking back — AI is bringing about a paradigm shift in how drugs are discovered. With increasing reliance on AI, there is hope that drug discovery will be more accurate, efficient and less time and cost consuming.
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    NEWS #PharmaBuzz

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    Alembic Pharma's Vadodara Facility Gets One USFDA 483
    Alembic Pharma's Vadodara Facility Gets One USFDA 483

    12 Mar 2025

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    12 Mar 2025
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    Alembic Pharma Q3 results: PAT falls 23.29% amid market headwinds
    Alembic Pharma Q3 results: PAT falls 23.29% amid market headwinds

    03 Feb 2025

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    03 Feb 2025
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    Alembic Pharma slides after Q3 PAT tumble 23% YoY to Rs 138 crore
    Alembic Pharma slides after Q3 PAT tumble 23% YoY to Rs 138 crore

    03 Feb 2025

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    03 Feb 2025
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    India's Alembic posts lower Q3 profit on weak domestic demand
    India's Alembic posts lower Q3 profit on weak domestic demand

    03 Feb 2025

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    https://www.reuters.com/business/healthcare-pharmaceuticals/indias-alembic-pharma-posts-lower-q3-profit-weak-domestic-demand-2025-02-03/

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    03 Feb 2025
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    Alembic Pharma Gets USFDA Approval For Brexpiprazole Tablets
    Alembic Pharma Gets USFDA Approval For Brexpiprazole Tablets

    15 Jan 2025

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    Alembic Pharma gets USFDA nod for seizure treatment drug
    Alembic Pharma gets USFDA nod for seizure treatment drug

    20 Dec 2024

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    20 Dec 2024
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    Drugs in Development

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    Alembic Pharma Gets USFDA Final Approval for Brexpiprazole Tablets

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    Brexpiprazole is a 5-HT2A receptor inhibitor and 5-HT1A/D2 receptor partial agonist. It is approved for the treatment of Major Depressive Disorder.


    Lead Product(s): Brexpiprazole

    Therapeutic Area: Psychiatry/Psychology Brand Name: Rexulti

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 15, 2025

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    Lead Product(s) : Brexpiprazole

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Alembic Pharma Gets USFDA Final Approval for Brexpiprazole Tablets

    Details : Brexpiprazole is a 5-HT2A receptor inhibitor and 5-HT1A/D2 receptor partial agonist. It is approved for the treatment of Major Depressive Disorder.

    Product Name : Rexulti

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 15, 2025

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    Alembic Pharma Gets USFDA Nod for Seizure Treatment Drug

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    Divalproex sodium is an GABA stimulating, anti-epileptic drug indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures.


    Lead Product(s): Divalproex Sodium

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 20, 2024

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    Lead Product(s) : Divalproex Sodium

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alembic Pharma Gets USFDA Nod for Seizure Treatment Drug

    Details : Divalproex sodium is an GABA stimulating, anti-epileptic drug indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    December 20, 2024

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    Alembic Pharma Gets Tentative USFDA Nod for Olopatadine Drug

    Details:

    Olopatadine HCl solution is a mast cell stabilizer, works by H1R antagonist, indicated for the treatment of ocular itching associated with allergic conjunctivitis.


    Lead Product(s): Olopatadine Hydrochloride

    Therapeutic Area: Ophthalmology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 04, 2024

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    Lead Product(s) : Olopatadine Hydrochloride

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alembic Pharma Gets Tentative USFDA Nod for Olopatadine Drug

    Details : Olopatadine HCl solution is a mast cell stabilizer, works by H1R antagonist, indicated for the treatment of ocular itching associated with allergic conjunctivitis.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    December 04, 2024

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    Alembic Pharma Gains USFDA Final Approval for Ivabradine Tablets, 5 mg and 7.5 mg

    Details:

    Ivabradine, is a small molecule oral blocker of HCN channels, indicated to reduce the risk of hospitalisation for worsening heart failure in adults with stable, symptomatic chronic heart failure.


    Lead Product(s): Ivabradine Hydrochloride

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Corlanor-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 12, 2024

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    Lead Product(s) : Ivabradine Hydrochloride

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alembic Pharma Gains USFDA Final Approval for Ivabradine Tablets, 5 mg and 7.5 mg

    Details : Ivabradine, is a small molecule oral blocker of HCN channels, indicated to reduce the risk of hospitalisation for worsening heart failure in adults with stable, symptomatic chronic heart failure.

    Product Name : Corlanor-Generic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    November 12, 2024

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    Alembic Pharma Gets US FDA nod for Diltiazem Hydrochloride ER capsules

    Details:

    Cardizem-Generic (diltiazem HCl) is an extended-release capsule, which has received ANDA approval by the US FDA for the treatment of hypertension.


    Lead Product(s): Diltiazem Hydrochloride

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Cardizem-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 11, 2024

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    Lead Product(s) : Diltiazem Hydrochloride

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Alembic Pharma Gets US FDA nod for Diltiazem Hydrochloride ER capsules

    Details : Cardizem-Generic (diltiazem HCl) is an extended-release capsule, which has received ANDA approval by the US FDA for the treatment of hypertension.

    Product Name : Cardizem-Generic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    November 11, 2024

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    Alembic Pharma Gets USFDA Nod for Generic Hypertension Treatment Capsules

    Details:

    Dilacor XR-Generic (diltiazem hydrochloride) is a calcium ion influx inhibitor, small molecule drug candidate indicated for the treatment of hypertension.


    Lead Product(s): Diltiazem Hydrochloride

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Dilacor XR-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 21, 2024

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    Lead Product(s) : Diltiazem Hydrochloride

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alembic Pharma Gets USFDA Nod for Generic Hypertension Treatment Capsules

    Details : Dilacor XR-Generic (diltiazem hydrochloride) is a calcium ion influx inhibitor, small molecule drug candidate indicated for the treatment of hypertension.

    Product Name : Dilacor XR-Generic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    October 21, 2024

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    Alembic Gains FDA Approval For Lamotrigine Extended-Release Tablets USP

    Details:

    Lamictal XR-Generic (lamotrigine) is a sodium channel alpha subunit blocker, which is indicated for adjunctive therapy for primary generalized tonic-clonic seizures & partial-onset seizures.


    Lead Product(s): Lamotrigine

    Therapeutic Area: Neurology Brand Name: Lamictal XR-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 03, 2024

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    07

    Alembic Pharmaceuticals Limited

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    Lead Product(s) : Lamotrigine

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alembic Gains FDA Approval For Lamotrigine Extended-Release Tablets USP

    Details : Lamictal XR-Generic (lamotrigine) is a sodium channel alpha subunit blocker, which is indicated for adjunctive therapy for primary generalized tonic-clonic seizures & partial-onset seizures.

    Product Name : Lamictal XR-Generic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    October 03, 2024

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    Alembic Gains USFDA Approval For Lamotrigine Extended-Release Tablets

    Details:

    Lamotrigine is a voltage-sensitive sodium channel inhibitor, indicated for adjunctive therapy for primary generalised tonic-clonic seizures and partial-onset seizures in 13 years and above patients.


    Lead Product(s): Lamotrigine

    Therapeutic Area: Neurology Brand Name: Lamictal

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 03, 2024

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    08

    Alembic Pharmaceuticals Limited

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    Lead Product(s) : Lamotrigine

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alembic Gains USFDA Approval For Lamotrigine Extended-Release Tablets

    Details : Lamotrigine is a voltage-sensitive sodium channel inhibitor, indicated for adjunctive therapy for primary generalised tonic-clonic seizures and partial-onset seizures in 13 years and above patients.

    Product Name : Lamictal

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    October 03, 2024

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    Alembic Pharma Gets USFDA Nod for Generic Drug Used to Treat Schizophrenia

    Details:

    Invega (paliperidone) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of patients with schizophrenia and schizoaffective disorder.


    Lead Product(s): Paliperidone Palmitate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 27, 2024

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    09

    Alembic Pharmaceuticals Limited

    India
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    Lead Product(s) : Paliperidone Palmitate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alembic Pharma Gets USFDA Nod for Generic Drug Used to Treat Schizophrenia

    Details : Invega (paliperidone) is an 5-HT2a and D2 receptor antagonist which is indicated for the treatment of patients with schizophrenia and schizoaffective disorder.

    Product Name : Invega-Generic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    September 27, 2024

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    Alembic Pharma Gets USFDA Nod for Generic Drug Used to Treat Schizophrenia

    Details:

    Paliperidone extended-release tablets are used to treat the symptoms of psychotic disorders, including schizophrenia both as a monotherapy and as an adjunct to mood stabilizers and antidepressants.


    Lead Product(s): Paliperidone

    Therapeutic Area: Psychiatry/Psychology Brand Name: Invega-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 27, 2024

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    Alembic Pharmaceuticals Limited

    India
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    Lead Product(s) : Paliperidone

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alembic Pharma Gets USFDA Nod for Generic Drug Used to Treat Schizophrenia

    Details : Paliperidone extended-release tablets are used to treat the symptoms of psychotic disorders, including schizophrenia both as a monotherapy and as an adjunct to mood stabilizers and antidepressants.

    Product Name : Invega-Generic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    September 27, 2024

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    Inspections and registrations

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    WHO-GMP

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    WHO GMP Certified

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    WHO GMP Certified

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    Alembic Pharmaceuticals Limited

    Name and address of WHO GMP certified Manufacturer : ALEMBIC LIMITED ALEMBIC PHARMACEUTICALS LIMITED (API DIVISION PANELAV) PANELAV

    Country : India

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    WHO GMP Certified

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    WHO GMP Certified

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    WHO GMP Certified

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    WHO GMP Certified

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    WHO GMP Certified

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    WHO GMP Certified

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    WHO GMP Certified

    Switzerland
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