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Policy and Regulation

Regulation Explore this Topic

Set Alert for Regulation

Shilpa Hit With FDA Warning Letter

India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.

FDA Manufacturing

Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications

Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.

Generic Drugs Regulation

Podcast: The UK's New Biosimilars Licensing Pathway

In this podcast discussion, Generics Bulletin editor David Wallace talks to Duncan Emerton, director of Custom Intelligence and Analytics for Informa Pharma Intelligence, about the UK's new licensing procedure for biosimilars.

Biosimilars Regulation
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Pricing Strategies; Reimbursement Explore this Topic

Set Alert for Pricing Strategies and Reimbursement

H2 Pharma Offloads Minority Interest To Private Equity

H2 Pharma, which specializes in both generic and OTC liquid formulations, is looking to climb to the next level after receiving an equity investment from Ardian.

Financing Companies

Hikma Eyes Another Hybrid Injectable With Arecor

London-listed Hikma has signed a second partnership agreement with Arecor, proposing to co-develop a 505(b)(2) hybrid injectable product for the US market.

Deals Companies

Shilpa Hit With FDA Warning Letter

India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.

FDA Manufacturing
See All

Intellectual Property Explore this Topic

Set Alert for Intellectual Property

H2 Pharma Offloads Minority Interest To Private Equity

H2 Pharma, which specializes in both generic and OTC liquid formulations, is looking to climb to the next level after receiving an equity investment from Ardian.

Financing Companies

Hikma Eyes Another Hybrid Injectable With Arecor

London-listed Hikma has signed a second partnership agreement with Arecor, proposing to co-develop a 505(b)(2) hybrid injectable product for the US market.

Deals Companies

Shilpa Hit With FDA Warning Letter

India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.

FDA Manufacturing
See All

Market Intelligence Explore this Topic

Set Alert for Market Intelligence

H2 Pharma Offloads Minority Interest To Private Equity

H2 Pharma, which specializes in both generic and OTC liquid formulations, is looking to climb to the next level after receiving an equity investment from Ardian.

Financing Companies

Hikma Eyes Another Hybrid Injectable With Arecor

London-listed Hikma has signed a second partnership agreement with Arecor, proposing to co-develop a 505(b)(2) hybrid injectable product for the US market.

Deals Companies

Shilpa Hit With FDA Warning Letter

India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.

FDA Manufacturing
See All
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