NKF Pharma Subsidiary Receives FDA Approval for Manufacturing Site Transfer of Desmopressin Acetate Injection

Regulation
โดย Jiemian·Read original
Summary · why it matters

NKF Pharma announced that its subsidiary Meitheal recently received notification from the U.S. FDA that the application to transfer the manufacturing site of Desmopressin Acetate Injection to NKF CDMO has been approved, covering the 4 microgram per milliliter and 40 microgram per 10 milliliter strengths. The original ANDA for this product was held by Teva Pharmaceuticals and has now been purchased and held by Meitheal. The reference listed drug is DDAVP held by JMNLR Holdings Inc., which was approved for marketing in the United States in 1984. There are currently five other generic drug companies selling the product in the U.S. market. The company stated that this approval confirms that its sterile injectable production lines and quality system meet U.S. cGMP standards, and will enrich its North American injectable pipeline while improving its overseas self-owned supply chain system.

Impact on stocks 2

Health Care▼ · 1 stocks
Others▲ · 1 stocks

Off-coverage companies 3

Meitheal Pharmaceuticals, Inc.Private▲ Positive
Regulationrelevance

Meitheal received FDA approval for manufacturing site transfer, strengthening its injectable pipeline.

Jianjin Pharmaceutical Co LtdPrivate± Mixed
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JMNLR Holdings IncPrivate± Mixed
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