Regulations Related To Lyophilized Powders

Mar 05, 2026 Leave a message

The production of lyophilized powders must comply with the requirements of Good Manufacturing Practice (GMP) for pharmaceuticals. Testing must adhere to the *Chinese Pharmacopoeia*, ISO standards, and other relevant domestic and international benchmarks. In the cosmetics sector, the National Medical Products Administration (NMPA) explicitly stipulates that any lyophilized powder product-whether its formulation includes, or the product claims to contain, Human Oligopeptide-1 or EGF-is deemed an illegal product. The illegal production or sale of counterfeit lyophilized pharmaceutical products will result in legal liability being pursued in accordance with laws such as the *Drug Administration Law of the People's Republic of China* and the *Criminal Law of the People's Republic of China*.

 

The production of lyophilized powder injections (for pharmaceutical use) must strictly comply with Good Manufacturing Practice (GMP) regulations. For instance, in February 2026, the lyophilized powder injection production line of a wholly-owned subsidiary of Sinopharm Modern successfully passed a GMP compliance inspection, thereby demonstrating its adherence to the requirements of the *Good Manufacturing Practice for Pharmaceuticals (2010 Revised Edition)*.

 

The testing of lyophilized powders must conform to the *Chinese Pharmacopoeia*, ISO standards, and other applicable domestic and international benchmarks. Testing parameters encompass physicochemical indicators (such as moisture content and reconstitution properties), microbial limits, active ingredient analysis, residual solvent analysis, and stability testing, all designed to ensure that product quality meets the certification requirements of GMP and other relevant standards.

 

Within the cosmetics sector, the National Medical Products Administration (NMPA) has explicitly mandated that any lyophilized powder product-whether Human Oligopeptide-1 or EGF has been added to its formulation, or the product claims to contain these ingredients-is classified as an illegal product.

 

The illegal production or sale of counterfeit lyophilized pharmaceutical products (such as counterfeit botulinum toxin), or of imported lyophilized pharmaceutical products that lack the requisite approval documentation, will result in legal liability being pursued under statutes such as the *Drug Administration Law of the People's Republic of China* and the *Criminal Law of the People's Republic of China*. Relevant case precedents indicate that such conduct may constitute the crime of producing or selling counterfeit drugs, or the crime of obstructing drug administration.

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