The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified.
This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.

Start Date20 Nov 2012

Sponsor / Collaborator

Genentech, Inc.

[+26]

100 Clinical Results associated with Strides Pharma, Inc.

0 Patents (Medical) associated with Strides Pharma, Inc.

Literatures (Medical) associated with Strides Pharma, Inc.

03 May 2025·JOURNAL OF BIOMATERIALS SCIENCE-POLYMER EDITION

Biofunctionalized polymeric nanoparticles for the enhanced delivery of erlotinib in cancer therapy

Article

Author: Vinukonda, Anjaneyulu ; Verma, Ritu ; Patil, Anasuya ; Suman Rudrangi, Shashi Ravi ; Tiwari, Ruchi ; Deva, Varsha ; Bhise, Manish R.

Erlotinib, a potent epidermal growth factor receptor (EGFR) inhibitor, faces bioavailability challenges due to poor water solubility and stability. This study aims to optimize erlotinib-loaded PLGA nanoparticles using a 3² factorial design to enhance drug delivery and therapeutic efficacy. The effects of PLGA concentration (R1) and NaTPP concentration (R2) on nanoparticle characteristics, including particle size, zeta potential, and polydispersity index (PDI), were investigated. The optimal formulation (F5) was identified and characterized, showing a particle size of 169.1 nm, a zeta potential of 20.0 mV, and a PDI of 0.146, indicating uniform and stable nanoparticles. Transmission electron microscopy (TEM) confirmed spherical nanoparticles with minimal aggregation, while X-ray diffraction (XRD) indicated an amorphous state of erlotinib. Formulation F5 demonstrated an entrapment efficiency of 81.9% and a yield of 83.0%. In-vitro drug release studies revealed a sustained release pattern with 90.0% cumulative release at 48 h, following Zero Order kinetics. Cytotoxicity assays showed low cytotoxicity across various cell lines. Statistical analysis confirmed the significant impact of formulation variables on nanoparticle properties. The systematic optimization of erlotinib-loaded nanoparticles has successfully identified formulation F5 as an optimal candidate with favorable characteristics, including minimal particle size, high stability, controlled drug release, and a safe cytotoxicity profile. Notably, the optimized formulation (F5) enhances therapeutic efficacy through improved bioavailability and targeted delivery, addressing the limitations of conventional therapies. These findings suggest that the optimized erlotinib-loaded nanoparticles hold significant potential for enhanced drug delivery and therapeutic efficacy.

International Journal of Peptide Research and Therapeutics

Complex Peptide Injectables: Development and Challenges

Author: Rapolu, Kishore ; Devadasu, Venkat Ratnam ; Vinukonda, Anjaneyulu ; Jadi, Rajendra Kumar

Abstract: Purpose: Complex peptide injectables represent an advanced class of pharmaceuticals with high therapeutic potential.These peptides, which mimic or modulate naturally occurring peptides in the body, offer targeted and effective treatment for various diseases.However, their structural complexity-influenced by length, sequence, and post-translational modifications-presents challenges in formulation, stability, and delivery.This review explores the development, challenges, and strategies for optimizing complex peptide injectables, with case studies highlighting their clin. applications.Methods: The review examines key formulation and delivery strategies employed to enhance the stability and bioavailability of complex peptides.Approaches such as nanoparticle encapsulation, carrier mol. conjugation, and sustained-release formulations are analyzed to determine their effectiveness in overcoming enzymic degradation and ensuring targeted delivery.Case studies from various therapeutic areas, including oncol., metabolic disorders, and infectious diseases, are used to illustrate real-world applications and advancements.Results: Despite formulation challenges, complex peptide injectables demonstrate high specificity and potency, enabling precise targeting with minimal off-target effects.Their unique ability to interact with biol. targets inaccessible to small mols. expands therapeutic options, making them highly promising for next-generation drug development.Innovations in formulation technol. have led to improved stability, controlled release, and enhanced efficacy, as evidenced by successful applications in cancer therapy, metabolic regulation, and antimicrobial treatments.Conclusion: This review provides a comprehensive overview of peptide drug development, associated challenges, and real-world case studies, contributing to the growing body of knowledge in peptide-based therapeutics.

News (Medical) associated with Strides Pharma, Inc.

24 Mar 2026

·www.fiercepharma.com

Strides recalls nearly 90K bottles of children's ibuprofen after contamination complaints

India’s Strides Pharma issued a voluntary recall for 89,592 bottles of liquid ibuprofen pain medication for children following reports of contamination. India’s Strides Pharma has issued a voluntary recall for 89,592 bottles of children's ibuprofen oral suspension in the U.S. following reports of contamination.The product, which was produced by Strides in India for Taro Pharmaceuticals' U.S. subsidiary, was recalled after complaints to the company flagged a “a gel-like mass and black particles” in the product, the FDA said in a posting on its website.The recall is ranked as Class II, which the U.S. regulator uses for recalled products that could cause temporary, medically reversible health consequences if used or where the probability of serious, irreversible adverse health effects is remote.The recalled product is widely sold in the U.S. as Children’s Motrin. The lots under recall are 7261973A and 7261974A, both with an expiration date of January 2027. The recalled pain reliever was distributed across the U.S., according to the FDA notice. To date, there have been no reports of adverse health incidents related to the recall.The product pull, which was initiated by Strides on March 2, follows news (PDF) from the company that its Singapore subsidiary received FDA approval in late January to manufacture acetaminophen and ibuprofen tablets at Strides’ main production facility in Bengaluru, India.

Drug Approval

23 Mar 2026

·www.drugs.com

Nearly 90,000 Bottles of Children’s Ibuprofen Recalled Nationwide

MONDAY, March 23, 2026 — If you have children’s ibuprofen at home, you may want to check the label. Nearly 90,000 bottles have been recalled over possible contamination, the U.S. Food and Drug Administration (FDA) said. The recall affects 89,592 bottles of Children’s Ibuprofen Oral Suspension made by Strides Pharma for Taro Pharmaceuticals USA, Inc . The issue? Some bottles may contain a foreign substance. The FDA said complaints described “a gel-like mass and black particles” found inside the medicine. The recall affects Children’s Ibuprofen Oral Suspension, USP with: A strength of 100 mg per 5 mL A strength of 100 mg per 5 mL A bottle size of 4 fluid ounces (120 mL) A bottle size of 4 fluid ounces (120 mL) Affected lot numbers 7261973A and 7261974A Affected lot numbers 7261973A and 7261974A Both have an expiration date of Jan. 31, 2027, and they were distributed nationwide. The company initiated the recall March 2 after receiving complaints about the ibuprofen. The FDA has classified it as a Class II recall . That means using the product could cause temporary or medically reversible health problems, but the risk of serious harm is considered low. Health officials say families should stop using the recalled ibuprofen right away. No additional instructions, such as returns or refunds, were included in the FDA’s report, NBC News said. Sources NBC News, March 19, 2026

21 Oct 2025

·pharma.economictimes.indiatimes.com

Strides to market Incepta’ contraceptive generic in Africa

New Delhi: Strides Pharma through its step-down wholly owned subsidiary has announced to market Incepta Pharmaceuticals WHO-prequalified contraceptive generic in Africa . The generic version, branded as ' Medogen SubQ ,' is equivalent to Pfizer’s subcutaneous depot medroxyprogesterone acetate (DMPA-SC), a three-month contraceptive that can be administered by healthcare workers or self-injected after appropriate training. Bangladesh-based Incepta Pharmaceuticals developed the therapy with support from the Children’s Investment Fund Foundation (CIFF) and the Gates Foundation . With this collaboration, Strides expands its Women’s Health franchise in Africa, augmenting its existing portfolio of strong brands like Vitafer, L-Gest, and many others. said Aditya Kumar , Executive Director, Business Development, Strides Pharma. “We are very excited to partner with Incepta to make available a version of this easy-to-use, long-acting reversible contraceptive, empowering women in the region to have greater control of their reproductive rights and choices,” he added. By Online Bureau ,

Drug Approval

100 Deals associated with Strides Pharma, Inc.

100 Translational Medicine associated with Strides Pharma, Inc.

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Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate ( HIV integrase x RT )	HIV Infections More	NDA/BLA

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