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    Company profile for Aurobindo Pharma Limited

    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    About

    Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market...
    Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.

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    Aurobindo Pharma Limitedindia-flag Flag
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    India
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    Plot no. 2, Maitrivihar, Ameerpet, Hyderabad - 500038 Andhra Pradesh
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    +91 (40) 6672 5000
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    "50 Years of Innovation: Mikart

    mic"50 Years of Innovation: Mikart's legacy and what's next in CDMO excellence"

    This week, SpeakPharma interviews Michael Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services. In this exclusive interview, Kallelis discusses how Mikart maintains its competitive edge through its Pharmaceutical Development Services team, quality control framework, and commitment to customized business solutions. Kallelis also explores the company's focus on liquid suspensions manufacturing, driven by growing demand from aging populations and pediatric patients, and explains how Mikart balances traditional family business values with modern innovation. HIGHLIGHTS// celebrating its 50th anniversary/ reputation for technical expertise/ how Mikart maintains its competitive edge Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey?  Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers. HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of full aggregate serialization/ attract both new and returning customers How has Mikart maintained its competitive edge in a constantly evolving pharmaceutical landscape? Our customers consistently tell us that what sets us apart is our technical expertise, high service level, and flexible, customized business terms. At the core of our competitiveness is our focus on Pharmaceutical Development Services (PDS). Mikart's PDS opinion leaders are actively engaged in business development and form early, collaborative relationships with our customers' technical teams. From the outset, our prospects and clients work directly with Mikart's experienced formulation chemists, analytical method developers, and process-oriented engineers to design robust, reproducible, and efficient processes. This hands-on development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team. The result is disciplined problem-solving, timely FDA submissions, and a "right-first-time" philosophy that accelerates time-to-market. We operate with a strong sense of urgency and consistently deliver a high level of customer satisfaction. What truly differentiates Mikart is our commitment to customized business terms that eliminate common roadblocks seen with other CDMOs. Our secret sauce is our exceptional service and flexibility in helping our customers bring innovative medicines to patients. HIGHLIGHTS// technical expertise, high service level/ flexible, customized business terms/ comprehensive quality control testing framework/ dedicated Quality Assurance and Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market What capabilities or services does Mikart offer today that didn't exist 10 or 20 years ago? Mikart was an early leader in serialization, implementing full capabilities well ahead of the industry timeline. This proactive approach has kept our packaging team in high demand. We also upgraded our tablet compression equipment to enhance both speed and reliability. To support growing development needs, we invested in new lab-scale development equipment, unit dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite dedicated to closed-system manufacturing of liquids and suspensions. Most recently, we launched a multi-million dollar expansion of our packaging lines to support higher-speed tablet filling, powder-in-bottle formats, and new liquid fill capabilities. HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/ multi-million dollar expansion of our packaging lines Why are liquid suspensions becoming such a key focus, and how is Mikart positioned? Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them. There is growing industry demand for high-quality suspension manufacturing, driven by the needs of the aging baby boomer population and pediatric patients. For both groups, swallowing tablets or capsules can be difficult, making oral liquid suspensions a more practical alternative. In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable. HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions offer pharmacological advantages/ improve dosing compliance How does Mikart balance tradition with innovation to meet modern customer demands?  At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority. Each customer is supported by a dedicated project manager who serves as their primary point of contact, along with direct access to key team members across departments. This structure ensures our customers are never isolated from our subject matter experts and can get timely, accurate answers to their questions. We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs. HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are never isolated from our subject matter experts/ we rely on market data and customer trends to guide our investments/ meet real market needs Looking ahead, what's in store for Mikart in the next 5-10 years? Mikart's strategic plan is now in full motion, and with the momentum we've built, 50 percent growth is within reach. This projection is backed by a strong pipeline of annual FDA filings, a growing customer base, and a robust portfolio of active Pharmaceutical Development Services projects. As we grow, we remain committed to delivering exceptional service and continuously evolving to meet the changing needs of our customers. With renewed political emphasis on domestic manufacturing for the US market, we are ideally positioned to support the rapid, cost-effective development and production of high-quality medicines here at home. As we approach our 50th anniversary in the CDMO industry, we celebrate our legacy and look forward with optimism to the opportunities ahead in the next 5 to 10 years. HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings 

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    17 Jul 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaIngredients for Innovative FormulationsIngredients for Innovative Formulations

    Ingredients for Innovative Formulations
    Ingredients for Innovative Formulations

    reelIngredients for Innovative Formulations

    This PharmaReel highlights Kirsch Pharma’s expertise in providing premium quality raw materials, custom blends, and tailor-made solutions. With 40+ years of expertise and certified quality (GMP, ISO 9001, FSSC 22000, Halal, Kosher), Kirsch supports pharma, biotech, and nutrition industries worldwide.

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

    Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

    Precise particle size control has become the cornerstone of modern pharmaceutical manufacturing. With highly potent active pharmaceutical ingredients (HPAPIs) and complex formulations driving unprecedented demand, micronization technology is no longer optional — it's critical. The market reflects this urgency. The global API micronization market will jump from US$ 2.47 billion in 2024 to US$ 3.68 billion by 2030 — a 49 percent surge driven by a robust 6.84 percent CAGR. What's powering this growth? Strategic innovation by industry leaders. Companies like Munit SA, Lonza, Catalent, Veranova, EUROAPI, AGC Pharma Chemicals, Hovione and Coral Drugs aren't just participating — they're defining the future of pharmaceutical particle engineering. The Micronization Landscape: How leading companies are advancing pharmaceutical particle engineering The API micronization space is being shaped by companies with specialized expertise. Munit’s proprietary fluid jet milling technology brings particle sizes down to the 1-micron level — critical for inhalation therapies. In addition, this technology enables precise control over particle size distribution without mechanical impact, making it ideal for heat-sensitive and high-potency APIs. With decades of hands-on experience, Munit ensures batch-to-batch consistency, scalability from R&D to commercial volumes, and full compliance with GMP standards.  Munit offers high-containment isolators — including glove boxes for R&D and half-suit isolators for larger batches — with industry-leading containment levels, limiting airborne drug exposure to as low as 0.025 micrograms per cubic meter. This makes it particularly well-suited for handling highly potent or sensitive compounds, exceeding the capabilities of other commercial-scale players like Catalent, who typically achieve containment levels of 0.05 micrograms per cubic meter or higher. EUROAPI has taken a broad particle engineering approach, offering both micronization and spray drying across multiple dosage routes — oral, inhaled, and parenteral. AGC Pharma Chemical leverages spray drying and amorphous solid dispersion technologies across small molecules, peptides, ADCs, and oligonucleotides, exemplifying the evolving intersection of particle engineering and modern drug delivery innovation. Coral Drugs delivers cutting-edge technology and customization capabilities that tailor particle sizes to specific client requirements across tablets, injectables, and topicals. This dynamic competitive landscape continues to evolve as companies expand capabilities and form strategic partnerships. This year, Dec Group announced the launch of their cutting-edge Micronization Suite, now operational in Brick, New Jersey, while Lonza joined the Centre for Continuous Manufacturing and Advanced Crystallisation, an international research hub, to develop innovative continuous processing and crystallization solutions. Selecting the right micronization partner: Key success factors In a pharmaceutical landscape increasingly defined by complexity, precision, and speed-to-market, the choice of a micronization partner can significantly influence a drug’s success. Among the players in this space, Munit SA has emerged as a trusted and strategic ally for pharmaceutical companies worldwide. But what exactly sets Munit apart in the micronization market? To begin with, Munit SA brings over 60 years of experience in particle size engineering. This legacy is not just a number; it reflects decades of accumulated knowledge, process refinement, and a deep understanding of how particle size impacts drug performance. In an industry where even minor deviations can compromise efficacy or safety, this level of experience is invaluable. It has delivered over 500 successful micronization projects to more than 150 customers globally. At its core, Munit SA is laser-focused on micronization and milling — not as ancillary services, but as its primary mission. Their facilities are designed for processing high-potency APIs, cytotoxic and cytostatic compounds, non-beta-lactam antibiotics, steroids, and controlled substances under stringent containment protocols. The company also handles inhalation products, peptides, biological drugs, generics, and R&D compounds. Whether it's micronization for ophthalmic formulations, transdermal or oral products, Munit offers a tailored approach. It stands as a world-leading provider of micronization services in inhalation powders with particle sizes of 1-5 microns and specialized oncology applications for small molecules. In an increasingly complex global landscape, Munit SA addresses supply chain challenges through its dual-site operational model, with facilities in Switzerland (Jetpharma SA) and Italy (Microchem S.r.l). This strategic setup mitigates risks from regulatory changes, geopolitical tensions, or environmental disruptions, ensuring continuous production and delivery of critical APIs. This resilience makes Munit a trusted partner for companies prioritizing business continuity. Why pharmaceutical companies choose Munit for advanced micronization and milling Munit’s proprietary MC Jet Mill is a testament to its engineering excellence. For heat-sensitive APIs, Munit’s cryogenic micronization process uses liquid nitrogen to cool materials, preventing thermal degradation and preserving the integrity of delicate molecules. This is particularly valuable for biologics and APIs with low melting points, where stability is paramount. Additionally, Munit’s under containment micronization employs advanced systems to safely handle HPAPIs, protecting both operators and the environment while meeting stringent regulatory standards.  Their co-micronization service, which processes APIs alongside excipients, further enhances formulation stability and solubility, offering innovative solutions for complex drug profiles. These capabilities, executed under Good Manufacturing Practices (GMP), make Munit a reliable choice for pharmaceutical companies seeking precision and quality. While micronization is Munit’s flagship, it offers milling services through an array of technologies, each suited to specific needs. The Pin Mill uses a grinding chamber and particle size reduction is achieved due impact against a high-speed pin rotor, producing sizes from 50 to 150 microns. It’s particularly effective for APIs needing improved flow for tableting, offering precise size control that ensures uniformity. The Quadro Co-Mill excels at soft de-lumping and homogenization, using a conical sieve and impeller to gently process powders without altering primary particle sizes. For tougher materials, the HammerMill C-10 employs hammer bars on a rotor to crush particles. State-of-the-Art Particle Engineering: Munit's strategic innovation push delivers next-gen solutions Munit’s leadership in micronization is underpinned by a deliberate and sustained investment in innovation — aimed at building the next generation of particle size engineering. In response to client challenges with condensation and product degradation, Munit developed a proprietary conditioning system that precisely controls humidity and temperature. Engineered with ergonomic design and fluid dynamics principles, their machine represents a qualitative leap in conditioning. Munit's new AIFA-approved Building C transforms the Italian hub's capacity. Equipped for high potent, toxic, cytotoxic, and cytostatic compounds, alongside hormones, it features cutting-edge safety systems and integrated technologies, enabling broader API processing with precision and compliance. Munit has merged quality assurance and regulatory affairs into one strategic unit, streamlining workflows and enhancing client responsiveness during critical validation phases. This delivers tailored regulatory support and accelerates time-to-market. These initiatives position Munit at the forefront of particle size engineering, where state-of-the-art innovation, regulatory excellence, and client-centric design converge to set new industry standards. Our view The API micronization market is projected to grow 49 percent to US$ 3.68 billion by 2030. In this evolving landscape, companies that combine deep technical expertise with operational resilience are positioned to capture the greatest value. Munit SA exemplifies this winning formula.
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    Impressions: 2282

    https://www.pharmacompass.com/radio-compass-blog/global-api-micronization-market-set-to-surge-49-by-2030-led-by-specialized-industry-pioneers

    #Phispers by PHARMACOMPASS
    10 Sep 2025
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    NEWS #PharmaBuzz

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    Apitoria Pharma Gets 5 Observations from USFDA for API Plant
    Apitoria Pharma Gets 5 Observations from USFDA for API Plant

    31 Aug 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/drug-approval/apitoria-pharma-receives-5-observations-from-usfda-for-api-facility-17697

    INDPHARMAPOST
    31 Aug 2025
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    Aurobindo's Unit Receive UK Approval for Biosimilar Breast Cancer
    Aurobindo's Unit Receive UK Approval for Biosimilar Breast Cancer

    27 Aug 2025

    // BUSINESS STD

    https://www.business-standard.com/industry/news/aurobindo-pharma-subsidiary-uk-approval-breast-cancer-drug-dazublys-125082601330_1.html

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    27 Aug 2025
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    Aurobindo Pharma Nears $5.5b Zentiva Acquisition
    Aurobindo Pharma Nears $5.5b Zentiva Acquisition

    20 Aug 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-leads-race-for-5-5-bn-zentiva-deal-set-to-be-indias-biggest-pharma-buyout/articleshow/123394210.cms

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    20 Aug 2025
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    Aurobindo Pharma Predicts China Plant EBITDA Break Even This Year
    Aurobindo Pharma Predicts China Plant EBITDA Break Even This Year

    17 Aug 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-pharma-expects-china-plant-to-break-even-at-ebitda-level-this-year/articleshow/123343017.cms

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    17 Aug 2025
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    Aurobindo Pharma`s Generics Pirfenidone Receives Approval in US
    Aurobindo Pharma`s Generics Pirfenidone Receives Approval in US

    11 Aug 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212596

    FDA
    11 Aug 2025
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    Aurobindo Pharma Q1 FY26 PAT Drops 10% YoY to Rs. 824 Cr
    Aurobindo Pharma Q1 FY26 PAT Drops 10% YoY to Rs. 824 Cr

    10 Aug 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/aurobindo-pharma-q1-fy26-pat-slips-10-yoy-to-rs-824-cr-17575

    INDPHARMAPOST
    10 Aug 2025
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    Drugs in Development

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    Aurobindo Pharma closing in on $5.5b Zentiva buyout

    Details:

    Zentiva holds a broad portfolio of generic and biosimilar products, including Affenid XL (methylphenidate hydrochloride) for the treatment of Attention-Deficit/Hyperactivity Disorder.


    Lead Product(s): Methylphenidate Hydrochloride,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Affenid XL

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Recipient: Zentiva

    Deal Size: $5,500.0 million Upfront Cash: Undisclosed

    Deal Type: Acquisition August 20, 2025

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    Lead Product(s) : Methylphenidate Hydrochloride,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Recipient : Zentiva

    Deal Size : $5,500.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Aurobindo Pharma closing in on $5.5b Zentiva buyout

    Details : Zentiva holds a broad portfolio of generic and biosimilar products, including Affenid XL (methylphenidate hydrochloride) for the treatment of Attention-Deficit/Hyperactivity Disorder.

    Product Name : Affenid XL

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    August 20, 2025

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    Aurobindo Pharma Arm gets USFDA Nod for Generic Blood Cancer Drug

    Details:

    Sprycel-Generic (dasatinib) is an inhibitor of multiple tyrosine kinases, which is indicated for the treatment of in certain types of cancer of bone marroe and blood.


    Lead Product(s): Dasatinib,Inapplicable

    Therapeutic Area: Oncology Brand Name: Sprycel-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Recipient: Eugia Pharma

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 23, 2025

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    Lead Product(s) : Dasatinib,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Recipient : Eugia Pharma

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Aurobindo Pharma Arm gets USFDA Nod for Generic Blood Cancer Drug

    Details : Sprycel-Generic (dasatinib) is an inhibitor of multiple tyrosine kinases, which is indicated for the treatment of in certain types of cancer of bone marroe and blood.

    Product Name : Sprycel-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    April 23, 2025

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    Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg

    Details:

    Rivaroxaban is an oral factor Xa inhibitor, which is indicated for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.


    Lead Product(s): Rivaroxaban,Inapplicable

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

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 14, 2025

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    Lead Product(s) : Rivaroxaban,Inapplicable

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg

    Details : Rivaroxaban is an oral factor Xa inhibitor, which is indicated for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation.

    Product Name : Xarelto-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    April 14, 2025

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    Auro Pharma Arm Gets USFDA Nod for Pazopanib Tablet

    Details:

    Vorient-Generic (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma & advanced soft tissue sarcoma who have received prior chemotherapy.


    Lead Product(s): Pazopanib Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Vorient-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 05, 2024

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    Auro Pharma Inc

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    Lead Product(s) : Pazopanib Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Auro Pharma Arm Gets USFDA Nod for Pazopanib Tablet

    Details : Vorient-Generic (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma & advanced soft tissue sarcoma who have received prior chemotherapy.

    Product Name : Vorient-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 05, 2024

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    Eugia Pharma Receives USFDA Approval for Pazopanib Tablets, 200 mg

    Details:

    Votrient-Generic (pazopanib HCl) is a multi-kinase inhibitor, which is indicated for the treatment of adults with advanced renal cell carcinoma & advanced soft tissue sarcoma.


    Lead Product(s): Pazopanib Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Votrient-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 05, 2024

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    Eugia Pharma

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    Lead Product(s) : Pazopanib Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Eugia Pharma Receives USFDA Approval for Pazopanib Tablets, 200 mg

    Details : Votrient-Generic (pazopanib HCl) is a multi-kinase inhibitor, which is indicated for the treatment of adults with advanced renal cell carcinoma & advanced soft tissue sarcoma.

    Product Name : Votrient-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 05, 2024

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    Aurobindo Pharma Receives USFDA Approval for Deflazacort Tablets in Multiple Strengths

    Details:

    Emflaza (deflazacort), a corticosteroid prodrug whose active metabolite acts as a glucocorticoid receptor agonist. It is approved for treating duchenne muscular dystrophy in patients 5 years & older.


    Lead Product(s): Deflazacort,Inapplicable

    Therapeutic Area: Genetic Disease Brand Name: Emflaza

    Study Phase: Approved FDFProduct Type: Steroid

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 02, 2024

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    06

    Aurobindo Pharma Limited

    India
    arrow
    BIOHK2025
    Not Confirmed

    Aurobindo Pharma Limited

    India
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Deflazacort,Inapplicable

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Aurobindo Pharma Receives USFDA Approval for Deflazacort Tablets in Multiple Strengths

    Details : Emflaza (deflazacort), a corticosteroid prodrug whose active metabolite acts as a glucocorticoid receptor agonist. It is approved for treating duchenne muscular dystrophy in patients 5 years & older.

    Product Name : Emflaza

    Product Type : Steroid

    Upfront Cash : Inapplicable

    December 02, 2024

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    Eugia Steriles Receives FDA Approval for New Injectables Facility

    Details:

    Lidocaine is a local anesthetic that's used to numb areas of the body before medical procedures, treat pain, and treat certain heart conditions.


    Lead Product(s): Lidocaine Hydrochloride,Inapplicable

    Therapeutic Area: Neurology Brand Name: Lidocaine HCl-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 09, 2024

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    07

    Eugia Pharma

    India
    arrow
    BIOHK2025
    Not Confirmed

    Eugia Pharma

    India
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    BIOHK2025
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Lidocaine Hydrochloride,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Eugia Steriles Receives FDA Approval for New Injectables Facility

    Details : Lidocaine is a local anesthetic that's used to numb areas of the body before medical procedures, treat pain, and treat certain heart conditions.

    Product Name : Lidocaine HCl-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    November 09, 2024

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    Aurobindo Gets USFDA Nod for Generic Version of Novo Nordisk's Vagifem

    Details:

    Vagifem-Generic (estradiol) is a USFDA approved steroid hormone which is indicated for the treatment of patients with atrophic vaginitis due to menopause.


    Lead Product(s): Estradiol,Inapplicable

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Vagifem-Generic

    Study Phase: Approved FDFProduct Type: Hormone

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 08, 2024

    blank

    08

    Aurobindo Pharma Limited

    India
    arrow
    BIOHK2025
    Not Confirmed

    Aurobindo Pharma Limited

    India
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Estradiol,Inapplicable

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Aurobindo Gets USFDA Nod for Generic Version of Novo Nordisk's Vagifem

    Details : Vagifem-Generic (estradiol) is a USFDA approved steroid hormone which is indicated for the treatment of patients with atrophic vaginitis due to menopause.

    Product Name : Vagifem-Generic

    Product Type : Hormone

    Upfront Cash : Inapplicable

    July 08, 2024

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    Aurobindo Receives USFDA Approval for Mometasone Furoate Nasal Spray

    Details:

    Nasonex-Generic (mometasone furoate monohydrate) nasal spray, a corticosteroid, has received FDA approval for treating allergic rhinitis symptoms.


    Lead Product(s): Mometasone Furoate,Inapplicable

    Therapeutic Area: Immunology Brand Name: Nasonex-Generic

    Study Phase: Approved FDFProduct Type: Steroid

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 19, 2024

    blank

    09

    Aurobindo Pharma Limited

    India
    arrow
    BIOHK2025
    Not Confirmed

    Aurobindo Pharma Limited

    India
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Mometasone Furoate,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Aurobindo Receives USFDA Approval for Mometasone Furoate Nasal Spray

    Details : Nasonex-Generic (mometasone furoate monohydrate) nasal spray, a corticosteroid, has received FDA approval for treating allergic rhinitis symptoms.

    Product Name : Nasonex-Generic

    Product Type : Steroid

    Upfront Cash : Inapplicable

    March 19, 2024

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    Aurobindo Pharma Gets USFDA Nod for Generic Antifungal Injection

    Details:

    Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.


    Lead Product(s): Posaconazole,Inapplicable

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Noxafil-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 27, 2023

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    10

    Aurobindo Pharma Limited

    India
    arrow
    BIOHK2025
    Not Confirmed

    Aurobindo Pharma Limited

    India
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    BIOHK2025
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Posaconazole,Inapplicable

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Aurobindo Pharma Gets USFDA Nod for Generic Antifungal Injection

    Details : Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.

    Product Name : Noxafil-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 27, 2023

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