La Pharma Limited

[Agenor Ramadan]

Afully integrated pharma company, Aurobindo Pharma features among the top 2 companies in India in terms of consolidated revenues. Aurobindo exports to over 150 countries across the globe with more than 90% of its revenues derived from international operations.

Ajanta Pharma is a specialty pharmaceutical company providing quality medicines across 30+ countries in the world. We enjoy leadership in multiple molecules and therapeutic segments through 1st to Market products.

AMO Pharma is a privately held emerging biopharmaceutical company developing new treatments for serious and debilitating diseases including rare genetic disorders. Our goal is to identify and advance a robust pipeline of promising therapies for patient populations with significant areas of unmet need.

The company is led by seasoned industry professionals with extensive experience in all phases of asset acquisition and drug development and commercialization. The AMO Pharma portfolio currently includes clinical stage investigational drugs to treat neuromuscular or CNS symptoms of rare diseases. We will expand our portfolio with other promising therapies that represent important advances in medicine and patient care as well as strong commercial opportunities.

Approved therapies are available for only about 10% of the 7,000+ known rare diseases. In addition, there are still a number of serious and debilitating diseases that affect larger populations and that do not have adequate treatments available. AMO Pharma is advancing a new model for drug development with the potential to address health challenges that collectively affect millions of people around the world. Most drug development programs, especially in orphan indications, present unique challenges. AMO Pharma combines a strong commitment to understanding the patient experience with expertise in all aspects of clinical research and global product commercialization to bring a new level of innovation and efficiency to drug development.

The site is secure.

The ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

1. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Your response is inadequate. Cross-contamination is not uniform, and your testing of control samples and placebo batches failed to scientifically prove that your products are free of contaminants from your visibly dirty equipment. You do not sufficiently address contamination recovered from product contact surfaces, and you fail to acknowledge that other locations and other sampling may reveal high levels of contamination. Your reserve sample testing alone is insufficient to determine the scope of the cross-contamination issue and mitigate risks associated with it. A failure to adequately clean (b)(4) units may lead to cross-contamination between drug products.

You do not provide interim control of equipment cleaning for the remaining (b)(4) used to manufacture your drug products. You have not submitted your finished drug products test results to determine the impact of cross-contamination observed during the inspection.

o In addition to this holistic remediation, provide specific CAPA activities that are being undertaken to effectively remediate the conditions that caused the specific cross-contamination incidents discussed above. Provide an independent review by your consultant that determines the effectiveness of your CAPA, including but not limited to:

A list of all enhancements to cleaning and maintenance procedures including specific frequencies and locations to be cleaned in all relevant equipment (e.g., (b)(4)).

Identify any other sources of cross contamination other than (b)(4) equipment, (b)(4) and (b)(4).

Determine the adequacy of your analytical methodology to identify residual carryover.

Your investigations into the unknown (unidentified) peaks detected in your reserve samples.

Supporting evidence to demonstrate that the challenges identified during your study, such as interference of product matrix and co-eluting peaks, were adequately resolved.

Adequacy of scope of the investigation and its related CAPA.

2. Your firm failed to thoroughly investigate any discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

In your response, you commit to conduct a review of all investigations from January 2021 to the end of 2023. Your response also indicates you hired a third-party consultant to perform an assessment of your documentation system.

We acknowledge your commitment to temporarily suspend production of all drugs manufactured on all dedicated and non-dedicated (b)(4) equipment for the U.S. market while you remediate the CGMP violations.

If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days1. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

1 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Pioneer in iron-based therapies, CSL Vifor is a global leader in iron deficiency and iron deficiency anaemia therapies, with a history dating back to 1872, when pharmacist Caspar Friedrich Hausmann opened a pharmacy in St. Gallen, Switzerland. Since then, we have proven our ability to identify and serve therapeutic areas and patients with significant unmet medical need.

Building on our heritage and expertise in iron deficiency therapy, and together with our joint company Vifor Fresenius Medical Care Renal Pharma, today we have a strong and rapidly growing presence in nephrology, and we are committed to launching the next generation of therapies to truly address the full spectrum of kidney disease.

We are a research-driven global biopharmaceutical company using next-generation technology platforms to discover and develop innovative medicines that can change the lives of people around the world. Click here to learn more.

Our R&D is focused in two areas. In Oncology R&D, we develop novel immuno-oncology therapies and in our Respiratory Innovation Centre we develop drug-device combination products for respiratory diseases. Click here to explore our focus areas.

We use partnerships across the globe to access cutting-edge scientific innovation and leverage our differentiated technology platforms for the benefit of patients. Click here to learn more about why we are a partner of choice.

At invoX, we aspire to improve lives by creating access to innovative medicines. This mission unites our employees and is why our teams come to work each day. Are you interested in a career at invoX? Click here to explore career opportunities.

We are Artios. We believe DDR-targeting therapies can play a significant role in the treatment of malignant disease, and we aim to take advantage of the full range of DDR therapeutic strategies to unlock new opportunities for patients.

Our team is recognized as innovators in DDR drug discovery, with experience that dates back to its inception. Our scientific founders, Niall Martin, PhD, and Graeme Smith, PhD, invented a blockbuster PARP inhibitor (now marketed as Lynparza (olaparib) by AstraZeneca) and pioneered successful DDR programs while at KuDOS. Our industry-leading expertise in this space has yielded a robust pipeline and platform with immense potential which has led to collaborations with major pharma partners.

Our capabilities allow us to move beyond a single approach, such as synthetic lethality, to develop drugs with a broad range of applications. Our approach includes developing inhibitors with monotherapy potential, overcoming acquired or de novo resistance to existing DDR-targeted therapies, including PARP inhibitors, supercharging existing DNA-targeting treatments through combinations, and expanding the reach of the immune response.

3a8082e126