Latest White Paper
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- 2025
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- 2025-06-16
New Product Alert – Ruxolitinib Phosphate
Ruxolitinib falls under the drug class known as Janus kinase inhibitors (JAK inhibitors). It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.This inhibition disrupts cytokine and growth factor signalling pathw... [More ]
Year 2025
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- 2025
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- 2025-06-16
New Product Alert – Ruxolitinib Phosphate
Ruxolitinib falls under the drug class known as Janus kinase inhibitors (JAK inhibitors). It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.This inhibition disrupts cytokine and growth factor signalling pathw... [More ]
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- 2025
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- 2025-05-26
Product Alert - Rimegepant
Rimegepant is a calcitonin gene-related peptide receptor antagonistOur Offerings*:Offers Crystalline Form (Innovator form 1.5 Hydrate)Alternate salt will provide 2 Years & 4 months advantage in Brazil & RussiaPlanning adequate capacity with a short lead time of 90 days.Lab samples and ATR av... [More ]
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- 2025
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- 2025-05-05
Product Alert – Mavacamten
CAS No. 1642288-47-8Mavacamten is an allosteric and reversible inhibitor selective for cardiac myosin. Mavacamten modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridg... [More ]
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- 2025
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- 2025-04-24
New Product Alert - Ripretinib
Ripretinib works by binding to two key regions of the kinase (the switch pocket and activation loop), locking it in an inactive state. This prevents the kinase from promoting abnormal cell growth, effectively inhibiting a wide range of mutations in KIT and PDGFRA kinases.Our Offerings*:Offers stable... [More ]
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- 2025
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- 2025-03-04
Product Alert - Lumateperone Tosylate
Lumateperone is a serotonin 5HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM), and a serotonin transporter (SERT) inhibitor. Unlike existing schizophrenia treatments, Lumateperone is a first-in-class molecule that provides selective and simultaneous modulation of seroton... [More ]
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- 2025
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- 2025-02-12
New Product Alert - Ribociclib
is a cancer medication that works by inhibiting the activity of specific enzymes called cyclin-dependent kinases (CDKs) 4 and 6. These enzymes play a critical role in the regulation of cell division, and their overactivity is commonly associated with the development of certain types of cancer, parti... [More ]
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- 2025
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- 2025-01-10
New Product Alert - Ruxolitinib & Salts
Ruxolitinib falls under the drug class known as Janus kinase inhibitors (JAK inhibitors). It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.This inhibition disrupts cytokine and growth factor signalling pathw... [More ]
Year 2024
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- 2024
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- 2024-12-18
Tech Sheet On Nilotinib Hydrochloride
Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, Nilotinib inhibited BCR-ABL-mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ chronic mye... [More ]
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- 2024
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- 2024-10-18
Tech Sheet – Mirabegron API
CAS no. 223673-61-8Mirabegron is a ß-3 adrenergic receptor agonist and a widely prescribed oral drug for treating overactive bladder (OAB). The drug improves symptoms associated with OAB, such as urinary urgency or urgency incontinence.Mirabegron was approved under the trade names Myrbetriq (US, 201... [More ]
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- 2024
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- 2024-09-25
Tech sheet – Apremilast
Dr. Reddy's API Offerings*:Dr. Reddy's is among the earliest generic API manufacturers globally for Apremilast API and filed the USDMF in September 2016 (Form-B) and June 2017 (Amorphous). Besides this, we have DMF filings in Canada and Brazil.Offers the same form as the innovator drug, facilitating... [More ]
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- 2024
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- 2024-05-31
Product Alert - Relugolix API
CAS No: 737789-87-6As an early mover in API development, we are committed to regulatory compliance, have DMFs filling in the US and Brazil, and plan to file the DMFs in significant markets. Our API is available in an anhydrous crystalline form (the innovator form), which can be provided in customize... [More ]
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- 2024
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- 2024-05-31
Tech Sheet on Enzalutamide Premix
Chemical Name:4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N- methylbenzamide.Dr. Reddy's API Offerings*:Innovator has filed an Enzalutamide premix amorphous form manufactured through spray drying, which uses API and HPMCAS as excipients. We offer a... [More ]
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- 2024
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- 2024-05-31
Product Alert – Mirogabalin Besylate
Dr. Reddy's Offerings*:Planning USDMF by January 2025Offers crystalline Form-1Non-GMP API and COA are available.Quality Assurance through cGMP API ManufacturingManufacturing facilities have successfully undergone inspections by international regulatory authorities.Partnerships with reliable key star... [More ]
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- 2024
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- 2024-04-22
Product Alert – Vonoprazan Fumarate
Dr. Reddy's Offerings:USDMF filed in februray 2024Offers crystalline innovator form.Our API adheres to ICH M7 guidelines for genotoxic impurity (GTI) profiles, and we are actively evaluating strategies for nitrosamine impurities. We have also employed a robust process to achieve the consistent polym... [More ]
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- 2024
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- 2024-02-21
Tech Sheet - Cabozantinib (S)-malate API
Cabozantinib S-malate is an orally bioavailable, small molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity.Dr. Reddy's API Offering*We offer Cabozantinib S-malate – Crystalline form N2 (Innovator form).Cabozantinib HCl is an alternate salt providing 505(b)(2) opp... [More ]
Year 2023
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- 2023
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- 2023-12-07
Product Alert – Deucravacitinib API
CAS no. 1609392-27-9Dr. Reddy's API OfferingWe are targeting crystalline Form and working on other amorphous solid dispersions (ASDs) as well. Our API adheres to ICH M7 guidelines for genotoxic impurity (GTI) profiles, and we are actively evaluating strategies for nitrosamine impurities. We have als... [More ]
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- 2023
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- 2023-12-04
Substantially Pure Carfilzomib Amorphous for Generic Launch
Kyprolis (carfilzomib) is a proteasome inhibitor that irreversibly binds to the N-terminal threonine-containing active sites of the 20S proteasome, the proteolytic core particle within the 26S proteasome. Carfilzomib had antiproliferative and proapoptotic activities in vitro in solid and hematologic... [More ]
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- 2023
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- 2023-11-06
Product Alert – Mavacamten API
CAS no. 1642288-47-8Mavacamten (Camzyos®) is the pioneering and singularly authorised cardiac myosin inhibitor designed to address hypertrophic cardiomyopathy (HCM) at its root cause. This unique compound acts as an allosteric and reversible inhibitor with a specific focus on cardiac myosin, allowin... [More ]
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- 2023
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- 2023-07-21
White Paper on Sugammadex API
Sugammadex is a medication used to reverse the effects of certain muscle-relaxing drugs (rocuronium and vecuronium) during anaesthesia. It works by forming a complex with these drugs, neutralizing their effects, and restoring muscle function, allowing for a rapid reversal of muscle relaxation. Sugam... [More ]
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- 2023
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- 2023-07-21
Tech Sheet on Pregabalin API
Pregabalin's precise mechanism of action is not fully understood, but studies suggest that it binds to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. This binding modulates the release of excitatory neurotransmitters and prevents the trafficking of the alph... [More ]
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- 2023
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- 2023-03-20
Product Alert – Niraparib API
Niraparib binds to the PARP enzyme and prevents it from repairing single-strand breaks in DNA. This causes the cancer cell's DNA to become more damaged, leading to cell death. Since cancer cells often have more DNA damage than healthy cells, they are more sensitive to the effects of PARP inhibitors ... [More ]
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- 2023
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- 2023-03-13
Product Alert – Tucatinib API
Tucatinib is a small molecule tyrosine kinase inhibitor that selectively targets human epidermal growth factor receptor 2 (HER2). HER2 is a transmembrane receptor that is overexpressed in some types of cancer, including breast cancer.Tucatinib binds to the intracellular domain of HER2, which blocks ... [More ]
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- 2023
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- 2023-03-06
Product Alert – Pazopanib API
Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR)-α and -β, fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T-cell kin... [More ]
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- 2023
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- 2023-01-20
Tech Sheet on Midostaurin API
Midostaurin is a small molecule that inhibits multiple receptor tyrosine kinases. In vitro biochemical or cellular assays have shown that Midostaurin or its major human active metabolites CGP62221 and CGP52421 inhibit the activity of wild type FLT3, FLT3 mutant kinases (ITD and TKD), KIT (wild type ... [More ]
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- 2023
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- 2023-01-09
Tech Sheet on Tofacitinib Citrate
Tofacitinib Citrate (Xeljanz) is an oral, small molecule drug used to treat adults with moderate to severe active rheumatoid arthritis (RA), active psoriatic arthritis, and moderate to severe ulcerative colitis. Tofacitinib works by blocking the body’s production of enzymes called Janus kinases (JAK... [More ]
Year 2022
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- 2022
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- 2024-08-04
Addressing the presence of mutagenic Azido impurities in Sartan APIs
In continuation to our efforts to understand the Azido impurities, we are evaluating the possibility of formation of two additional Azido impurities - Chloro methyl azido impurity and 4-Chloro azido methyl tetrazole impurity in Losartan potassium. Based on detailed synthetic landscape, it is found t... [More ]
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- 2022
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- 2022-11-04
Tech Sheet on Dutasteride
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the prostate gland's initial development and subsequent enlargement. Testosterone is converted to DHT by the enzyme 5-alpha-reductase, which exists as 2- isoforms, type 1 a... [More ]
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- 2022
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- 2022-10-14
Tech Sheet on Linagliptin
Linagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4), an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of ... [More ]
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- 2022
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- 2022-10-12
Tech Sheet on Voriconazole
Voriconazole (Vfend®) is an azole antifungal indicated for invasive aspergillosis candidemia (non- neutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds, and esophageal candidiasis. Furthermore, it is used to treat serious infections caused by scedosporium apio... [More ]
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- 2022
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- 2022-08-03
Co-Crystal and Customized Particle Size for Early Launch Opportunity of Siponimod API
Siponimod is an oral, second-generation sphingosine-1-phosphate (S1P) receptor modulator. S1P receptor modulators can inhibit the egress and recirculation of lymphocytes from lymph nodes, a therapeutic strategy for treating certain autoimmune diseases.Siponimod is the first and only treatment for pa... [More ]
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- 2022
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- 2022-07-29
New Product Alert – Lumateperone Tosylate API
Lumateperone is a serotonin 5HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM), and a serotonin transporter (SERT) inhibitor. Unlike existing schizophrenia treatments, Lumateperone is a first-in-class molecule that provides selective and simultaneous modulation of seroton... [More ]
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- 2022
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- 2022-06-15
Tech sheet: Dr. Reddy's Bempedoic Acid API Offerings
Bempedoic acid (Brand: Nexletol, Innovator: Esperion) is an essentially new, oral treatment option approved for patients needing further LDL-C lowering beyond maximally tolerated statin therapy. Bempedoic acid is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for ... [More ]
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- 2022
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- 2022-04-04
Tech sheet: Dr. Reddy's Olaparib API Offerings
Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostases, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib is indicated:As monotherapy in patients with deleterious or... [More ]
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- 2022
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- 2022-03-30
Tech sheet: Dr. Reddy's Enzalutamide API Offerings
Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signalling pathway. Enzalutamide has been shown to inhibit androgen binding to androgen receptors competitively and consequently inhibits nuclear translocation of androgen receptors and their interac... [More ]
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- 2022
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- 2022-02-22
Tech Sheet - Dr. Reddy’s Eribulin Mesylate API offerings
Eribulin Mesylate (Halaven®) is a microtubule inhibitor indicated to treat patients with:Metastatic breast cancer who have previously received at least two chemotherapeutic regimens to treat metastatic disease.Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing ... [More ]
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- 2022
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- 2022-02-09
Tech Sheet – Dr. Reddy’s Fexofenadine API offerings
Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Fexofenadine Hydrochloride is indicated for:The relief of symptoms associated with seasonal allergic rhinitis in patients ≥ 2 years of age.To treat u... [More ]
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- 2022
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- 2022-02-04
Tech Sheet - Dr. Reddy’s Azacitidine API offerings
Azacitidine is a nucleoside metabolic inhibitor indicated to continue treating adult patients with acute myeloid leukemia. In addition, it is indicated for use in adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count r... [More ]
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- 2022
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- 2022-02-04
Tech Sheet - Dr. Reddy’s Ramipril API offerings
Ramipril is an angiotensin-converting enzyme (ACE) inhibitor indicated for treating hypertension to lower blood pressure. ACE inhibitors inhibit the angiotensin-converting enzyme (ACE) actions, thereby reducing the production of angiotensin II and decreasing the breakdown of bradykinin. The decrease... [More ]
Year 2021
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- 2021
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- 2021-12-17
Tech Sheet - Dr. Reddy’s Gemcitabine API offerings
Gemcitabine Hydrochloride is an analog of the antimetabolite nucleoside deoxycytidine with antineoplastic activity. Gemcitabine is converted intracellularly to the active metabolites difluorodeoxycytidine di-and triphosphate (dFdCDP and dFdCTP)dFdCDP - Inhibits ribonucleotide reductase, decreasing t... [More ]
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- 2021
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- 2021-12-02
Tech Sheet: Dr. Reddy’s Abiraterone Acetate API offerings
Abiraterone is an orally active inhibitor of the steroidal enzyme CYP17A1 (17 alpha-hydroxylase/C17,20 lyase). It inhibits CYP17A1 selectively and irreversibly via a covalent binding mechanism. Abiraterone is a CYP17 inhibitor indicated in combination with prednisolone to treat patients with metasta... [More ]
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- 2021
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- 2021-10-08
White Paper: Redyx: Remdesivir formulation developed at Dr. Reddy’s under the license from Gilead
Remdesivir is the First treatment approved by the US FDA for the treatment of COVID-19 in adult and paediatric patients (12 years or older, and weighing at least 40 kg) that require hospitalization. It is an inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), essential for viral replic... [More ]
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- 2021
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- 2021-08-17
Whitepaper : Dr.Reddy's 2 DG- A promising treatment in hospitalized COVID-19 patients
2-Deoxy-D-Glucose (2-DG) is an anti-viral and anti-inflammatory drug developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS) of Defense Research and the Development Organization (DRDO). Dr. Reddy's collaborated with DRDO to conduct clinical trials for 2-DG in COVID-19 patients. Ba... [More ]
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- 2021
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- 2021-08-17
Techsheet: Dr.Reddy's Lenvatinib API offerings
Lenvima is an oral tyrosine kinase inhibitor approved in multiple indications, including differentiated thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma.We offer two polymorphic forms:1) Lenvatinib Mesylate MIBK solvate2) Lenvatinib Mesylate Form-C.A MIBK sol... [More ]
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- 2021
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- 2021-06-18
ROXADUSTAT - a multipronged development strategy
In this whitepaper, we outline how various strategies for the development of Roxadustat resulted in a successful filling of the USDMF in March 2020 to help our partners across geographies provide patients early treatment access.Roxadustat is a first-in-class small molecule oral hypoxia-inducible fac... [More ]
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- 2021
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- 2021-05-19
Dr.Reddy's Apremilast API and finished formulation offerings.
Dr. Reddy's is one of the leading API pharma companies supplying Apremilast API globally, and has led the USDMF filing in September 2016 (Form-B) and June 2017 (Amorphous).Apremilast, is an anti-inflammatory agent modulating a wide range of inflammatory mediators in psoriasis and psoriatic arthritis... [More ]
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- 2021
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- 2021-05-03
Dr. Reddy’s Fosaprepitant API offerings
Fosaprepitant is indicated for preventing acute and delayed nausea and vomiting associated with moderately or highly emetogenic chemotherapy combined with other antiemetic agents. The US FDA and EMA approved fosaprepitant in 2008, and the PMDA in 2011. As of December 2020, this corresponds to an API... [More ]
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- 2021
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- 2021-04-15
Apixaban API – ready-to-compress granules and finished dosage forms
Dr. Reddy's is among the earliest global generic API manufacturers for Apixaban API and filed the USDMF in September 2015. Our customers have access to the high-quality API in customized particle sizes to facilitate formulation development.Apixaban is an anticoagulant medication approved under the t... [More ]
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- 2021
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- 2021-04-06
Apalutamide API – an attractive NCE-1 opportunity for generic pharma companies
Prostate cancer accounts for 7.3% of all incident cases of cancer globally, as per estimates released by Globocan 2020. The 5-year prevalence of prostate cancer is estimated at ~ 5 million worldwide, making it the second most common cancer among men.Apalutamide is an oral second-generation, nonstero... [More ]
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- 2021
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- 2021-04-06
Colloidal Iron Complex Formulations – Understanding and Developing the Process
This whitepaper describes the challenges involved in developing iron-carbohydrate complexes, including the parameters required to demonstrate physicochemical equivalence and summarises our expertise in addressing them. Iron carbohydrate complexes are a hybrid of inorganic and organic molecules.... [More ]
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- 2021
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- 2021-02-09
Rivaroxaban from Dr.Reddy’s: Full basket offerings of API and Finished formulations
Dr. Reddy’s is among the earliest generic API manufacturers globally for Rivaroxaban API and filed the USDMF in March 2014. Dr. Reddy’s process involves a selective and efficient chemical transformations that offer distinctive advantage for quality and manufacturability. The process eliminates ... [More ]
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- 2021
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- 2021-01-22
Dr. Reddy's Mirabegron API offering in both alpha and amorphous form
Read through our technical sheet on Mirabegron API to get a glimpse of our multi-step scalable synthetic approach with effective analytical characterization resulting in a highly pure API. Dr. Reddy's is among the earliest generic API manufacturers globally and filed the USDMF for Mirabegron AP... [More ]
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- 2021
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- 2021-01-13
Palbociclib – how a novel process development approach provides IP advantages
This whitepaper outlines how Dr. Reddy's holistic development approach can help our API partners across geographies to provide patients early access to the generic alternative of Palbocicilb while gaining or maintaining competitive advantages.Our team of process experts draw on their integrated... [More ]
Year 2020
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- 2020
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- 2020-11-25
Dr. Reddy's Elagolix API offering leverages a well rounded Quality by Design approach
The technical product sheet on our Elagolix API describes the Quality by Design (QbD) approach taken by Dr. Reddy's R&D team to develop the product. As a result, Dr. Reddy's is one of the first and few generic API manufacturer in the world to successfully validate the Elagolix API process early ... [More ]
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- 2020
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- 2020-07-20
Sacubitril/Valsartan (LCZ696) – Bringing yet another advantage through innovative API offerings
Our team of process and analytical experts draw on their integrated understanding in both the development and manufacturing of the API and the formulation. This is of particular importance when it comes to the characterization of a molecular complex which is critical for a successful API and formula... [More ]
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- 2020
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- 2020-07-10
Dr. Reddy’s Flow Chemistry experts share their perspectives in panel discussion of Chemistry Today
June 2020Dr. Reddy’s Flow Chemistry experts, Srividya Ramakrishnan and Rakeshwar Bandichhor, recently participated in the panel discussion of Chemistry Today, where they shared their perspectives on flow technology and its potential to become a superior manufacturing alternative for complex synthesi... [More ]
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- 2020
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- 2020-05-20
A closer look on how Dr. Reddy's met the stringent regulatory requirement of genotoxic impurities in Ranolazine
Genotoxic impurities (GTIs) have recently challenged the pharmaceutical industry by virtue of their presence at a level of parts per million (ppm) in drug products, especially in high dosage molecules like Ranolazine, which has a prescribed maximum daily dosage (MDD) of 2000 mg.In this whitepaper, w... [More ]
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- 2020
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- 2020-05-07
Famotidine and Nizatidine APIs: NDMA controlled, customized particle distribution, supply chain security
For more than two decades, Dr. Reddy's has been recognized as one of the largest manufacturers of H2 receptor antagonist APIs such as Famotidine and Nizatidine. Our Tidine APIs are used by formulation companies across Europe, US, Japan, Middle-East and Asia Pacific.Manufactured and controlled in acc... [More ]
Year 2019
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- 2019
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- 2019-10-17
Meeting the New Regulatory Requirements in Sartan API Production
Manufacturer of APIs are now required to review their manufacturing processes and prove the absence of nitrosamine impurities. This whitepaper outlines the regulations and a case study on how Dr. Reddy’s Sartan API’s (such as Valsartan) already addresses future requirements.You can review our Sartan... [More ]
Disclaimer
No information on this website, including any reference to any product or service constitutes an offer for sale or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, in certain cases, at Dr. Reddy's sole discretion, and subject to local legal requirement, the research quantities of such products may be offered for the purpose of regulatory submissions under Section 107A of the Indian Patent Act (Bolar exemption), wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the product or service including, patent scenario in their respective markets and will be responsible for all patent related liabilities Dr. Reddy's disclaims all warranties, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose and non-infringement.