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Manufacturing

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Teligent Cites Remediation-Related Activites For Poor Quarter

New Jersey-based Teligent reported a low quarter as the company continues to focus on remediation measures to lift the FDA warning letter hanging over its Buena New Jersey manufacturing facilty. Teligent has also recently recalled a batch of its 4% lidocaine hydrochloride topical solution because the firm’s testing found it to be super potent.

Generic Drugs Sales & Earnings

Alvotech Suffers Delay On Higher-Strength Adalimumab In US

Alvotech has suffered a setback in its attempt to gain the first US FDA approval for a higher-strength biosimilar adalimumab rival to Humira, after obstacles preventing facility inspections led the agency to defer action on the firm’s AVT02 candidate.

Biosimilars Regulation

Premier Invests In Exela To Procure Shortage-Hit Generic Injectables

As hospital drug shortages continue to bite in the US, a group purchasing organization has invested in generic injectables specialist Exela Pharma Sciences to garner uninterrupted supply of 19 pharmaceutical products.

Deals Generic Drugs

FDA Details Observations At Stricken Jubilant Roorkee Facility

Indian firm Jubilant Pharmova demonstrated a host of deficiencies at its manufacturing facility in Roorkee, including for cleanliness, laboratory controls, control procedures and data management, according to a US FDA Form 483 that has just been unveiled.

Manufacturing Compliance

Japan’s Sawai Benefits In Domestic Market From Rivals’ Supply Misery

Sawai was strong in Japan and weak in the US in the first financial quarter of its 2022 financial year, as analysts called on the Japanese firm to improve supply capacity as a “crucial first step towards expanding market share.”

Generic Drugs Manufacturing

Phlow CEO Reveals Possible Partnerships With ‘Global Generics Manufacturing Companies’

In the second part of an exclusive interview with Generics Bulletin, Phlow CEO Eric Edwards has revealed that the company is at the precipice of entering into agreements to co-develop essential medicines in the US. Edwards has also recognized the Biden administration’s efforts to secure domestic supply, offering suggestions on how to fix “America’s broken supply chain.”

United States Deals

‘Critical To Bring Back Domestic Manufacturing Of Key Essentials’ Insists Phlow CEO

In an exclusive interview with Generics Bulletin, Phlow Corp CEO Eric Edwards has criticized the growing list of drug shortages in the US. He outlined the government-backed company’s objective of tackling drug shortages and supply chain vulnerabilities, to create a national stockpile of essential medicines.

United States Generic Drugs

Xellia CEO Questions Key Ingredients Reliance Of US And Europe

In an exclusive interview with Generics Bulletin, the CEO of API and FDF manufacturer Xellia Pharmaceuticals, expresses concern over supply chain resilience of the US and the EU, as he points out the weaknesses exposed by the pandemic. The company has also announced the release of its first anti-infectives manufactured at its newly operational Cleveland site. 

Generic Drugs Manufacturing

FDA Begins cGMP Reinspection Of Teligent’s Key Facility

Teligent is relying upon the FDA approval of its manufacturing capacity at Buena, New Jersey to reintroduce its products in the market and “significantly expand” its production capabilities within the sterile injectables segment. 

Generic Drugs Sales & Earnings
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